Registration Number
Profile Type
CITY
STATE
Country
Scheme
A & M Biomedical
MD19.4484
Single
Laguna Hills
CA
USA
I.S.EN ISO13485:2012
Contract manufacture and distribution of non-sterile and sterile, non-active and active medical devices.
AADCO Medical Inc.
MD19.4659
Primary
Randolph
VT
USA
I.S.EN ISO13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Gel Pads and Patient Positioners, Conventional and MRI Safe Examination Lamps and Ceiling Suspension Systems for Medical ExaminationISO 9001:2008 Scope: The Design, Manufacture and Distribution of Ergonomic X-Ray Protective and MRI Safe Medical Equipment and Devices
AADCO Medical Inc.
MD19.4659/A
Secondary
Randolph
VT
USA
I.S.EN ISO13485:2012
IS EN ISO 13485 Scope: The Design, Manufacture and Distribution of Non-Sterlie Gel Pads and Positioners for Patient Positioning during Medical ExaminationISO 9001:2008 Scope: The Design, Manufacture and Distribution of Ergonomic X-Ray Protective and MRI Safe Medical Equipment and Devices
MD19.2326
Single
Dublin 14
Ireland
I.S.EN ISO13485:2012
The Manufacture and Distribution of Molecular Controls for the In-Vitro Diagnostic Industry. The Contract Manufacture and Supply of Biological Raw Materials for the In-Vitro Diagnostic Industry.
MD19.8091 MD19.4143/B MD19.4143/C MD19.4143
Single Secondary Primary Secondary
ONTARIO Paris Ontario Ontario
USA France USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
The Contract Manufacture of Intraocular Lenses The Design and Development, Manufacture, and Distribution of Intraocular Lenses. The Design and Development, Manufacture, and Distribution of Intraocular Lenses. The Design and Development, Manufacture, and Distribution of Intraocular Lenses.
Abbott Ireland
MD19.3772
Single
Co Sligo
Ireland
I.S.EN ISO13485:2012
The design, manufacture, and distribution of adult and paediatric enteral Feeding kits, including tubes, connectors and feeding bags. The distribution and the servicing of enteral feeding pumps.
ABSL Power Solutions, Inc.
AS19.4993
Single
Longmont
CO
USA
AS 9100 - D
ACM Machining, Inc.
19.4781/A
Secondary
Rancho Cordova
CA
USA
ISO 9001:2008
ACM Machining, Inc.
19.4781
Primary
Rancho Cordova
CA
USA
ISO 9001:2008
TL19.4464
Single
Sunnyvale
CA
USA
TL 9000 R5.5/R5.0
Acumuladores Industriales EnerSys, S.A.
19.4402
Primary
Vizcaya
Spain
ISO 9001:2015
Sales and installation of reserve power industrial batteries. Sales and aftersales of motive power industrial batteries and chargers through its facilities and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys, S.A.
19.4402/A
Secondary
Barcelona
Spain
ISO 9001:2015
Sales and installation of reserve power industrial batteries. Sales and aftersales of motive power industrial batteries and chargers through its facilities and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys, S.A.
19.4402/B
Secondary
Madrid
Spain
ISO 9001:2015
Sales and installation of reserve power industrial batteries. Sales and aftersales of motive power industrial batteries and chargers through its facilities and Head Offices in Zamudio and its branches in Spain.
Acumuladores Industriales EnerSys, S.A.
19.4402/C
Secondary
Valencia
Spain
ISO 9001:2015
Sales and installation of reserve power industrial batteries. Sales and aftersales of motive power industrial batteries and chargers through its facilities and Head Offices in Zamudio and its branches in Spain.
Adhesive Packaging Specialties, LLC
AS19.1849
Single
Peabody
USA
AS 9100 - D
Adhesives Research Ireland Ltd
MD19.5061
Single
Raheen, Limerick
Ireland
I.S.EN ISO13485:2012
Adhesives Research Ireland Ltd.,
19.5061
Primary
Raheen, Limerick
Ireland
ISO 9001:2015
The design and development, manufacture and sale of speciality adhesives, speciality coated products and adhesive coated products for medical, pharmaceutical, automotive, aerospace and general manufacturing industries.
ADTRAN GmbH
14.0432/I
Secondary
Munich
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH
TL19.1270/H
Secondary
Greifswald
Germany
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
ADTRAN GmbH
TL19.1270/I
Secondary
Munich
Germany
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
ADTRAN GmbH
14.0432/H
Secondary
Greifswald
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
ADTRAN GmbH Facility
TL19.1270/F
Secondary
Berlin
Germany
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
ADTRAN GmbH Facility
14.0432/F
Secondary
Berlin
Germany
ISO 14001:2004
Design, development, product management and related activities of Broadband Access related telecommunication products and solutions.
TL19.1270/J
Secondary
Hyderabad
India
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
COMPANY
Aalto Bio Reagents Ltd Aaren Laboratories, LLC AAREN Scientific France AAREN Scientific, Inc. AAREN Scientific, Inc.
Actiontec Electronics, Inc.
ADTRAN India Pvt Ltd
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
CA CA CA
MA
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
Design, Production, and Test Solutions of High Reliability, Tailored Lithium-Ion Batteries, for Specialty Applications in the Space, Aviation and Select Defense Marketplaces Contract machine shop for the manufacture of metal components for the oil and gas industry, automotive filtration and general machining. Contract machine shop for the manufacture of metal components for the oil and gas industry, automotive filtration and general machining. TL9000-HSV Scope: Design, Sales and Servicing of Broadband Products for Telecommunications Service Providers for the following service categories: 6.2.3.2 Wireless Modems, 7.5.1 Technical Assistance and Customer Support Centers.ISO 9001 Scope: Design, Sales and Servicing of Broadband Products for Telecommunications Service Providers.
The Custom Packaging of Single and Multi-Component Adhesive Systems for Aerospace and Industrial Applications. The design and development, and manufacture of adhesives, adhesive-coated films, laminates and other specialty films for use in the medical devices industry.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
TL19.1270/A
Secondary
Melbourne
Victoria
Australia
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
ADTRAN, Inc.
TL19.1270
Primary
Huntsville
AL
USA
TL 9000 R6.0/R5.0
The Assets and Processes involved in ADTRAN'S Provision of the Design, Development, Implementation and Maintenance Activities of Information and Communication Technology (ICT).
ADTRAN, Inc.
14.0432
Primary
Huntsville
AL
USA
ISO 14001:2004
Advance Medical Designs
MD19.3577/B
Secondary
Marietta
GA
USA
ISO 13485/CMDCAS
Advance Medical Designs
MD19.3577/A
Secondary
Marietta
GA
USA
ISO 13485/CMDCAS
Advance Medical Designs
MD19.3577
Primary
Marietta
GA
USA
ISO 13485/CMDCAS
AdvanDx
MD19.4841
Single
Woburn
MA
USA
I.S.EN ISO13485:2012
Advant Medical Ltd
MD19.2484/A
Secondary
Co Galway
Ireland
I.S.EN ISO13485:2012
Advant Medical Ltd
MD19.2484
Primary
Co. Galway
Ireland
I.S.EN ISO13485:2012
Aerogen Ltd
MD19.3129
Single
Co. Galway
Ireland
I.S.EN ISO13485:2012
Ai Biomed
MD19.8047
Single
Santa Barbara
CA
USA
ISO 13485/CMDCAS
Airmar Technology Corporation
19.3301/A
Secondary
Milford
NH
USA
ISO 9001:2015
Airmar Technology Corporation
19.3301
Primary
Milford
NH
USA
ISO 9001:2015
AIXTRON, Inc.
19.3133
Single
Sunnyvale
CA
USA
ISO 9001:2015
The design, manufacture and service of Thin Film capital equipment for advanced semiconductor manufacturing.
AIXTRON, Inc.
14.0255
Single
Sunnyvale
CA
USA
ISO 14001:2015
The design, manufacture, service and marketing of thin film capital equipment for advanced semiconductor manufacturing.
Alcor Scientific Inc.
MD19.4997
Single
Smithfield
RI
USA
ISO 13485/CMDCAS
The Design, Manufacture, and Distribution of Enteral Nutrition Feeding Pumps, Enteral Feeding Sets, and IVD Systems for Haemotology.
Alden Medical, LLC
MD19.4504
Single
West Springfield
MA
USA
I.S.EN ISO13485:2012
Alfa Scientific Designs, Inc.
MD19.3050
Single
Poway
CA
USA
ISO 13485/CMDCAS
Allard Support UK Limited
19.2658
Single
Co Louth
Ireland
ISO 9001:2008
MD19.4528/A
Single
Acton
USA
I.S.EN ISO13485:2012
19.5564
Single
Co Cork
Ireland
ISO 9001:2008
Altaviz, LLC
MD19.4941
Single
Irvine
CA
USA
I.S.EN ISO13485:2012
American Bio Medica Corporation
MD19.4136
Primary
Kinderhook
NY
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and related equipment utilizing lateral flow immunoassay technology used in the rapid screening test of drugs of abuse, infectious diseases and other analytes.
American Bio Medica Corporation
MD19.4136/A
Secondary
Logan Township
NJ
USA
ISO 13485/CMDCAS
The design/development, manufacture and distribution of in-vitro diagnostic test kits and related equipment utilizing lateral flow immunoassay technology used in the rapid screening test of drugs of abuse, infectious diseases and other analytes.
AMETEK Aegis, Inc.
19.3116
Single
New Bedford
MA
USA
ISO 9001:2015
Ametek Canada LP
19.808
Single
Calgary AB
Canada
Canada
ISO 9001:2015
AS19.4721
Primary
Binghamton
NY
USA
AS 9100 - C
COMPANY ADTRAN Networks Pty Ltd.
Allen Medical Systems Alpha Healthcare Ltd/Alpha Primary Care
AMETEK Power and Data Systems
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
The assets and processes involved in ADTRAN's provision of the design, development, implementation and maintenance activities of information and Communication Technology (ICT). The design and development, manufacture and distribution of sterile and non-sterile disposable patient drapes, equipment covers, medical waste bags, high pressure lines, pressure monitoring lines, decanters and related devicesfor infection control and fluid management. The design and development, manufacture and distribution of sterile and non-sterile disposable patient drapes, equipment covers, medical waste bags, high pressure lines, pressure monitoring lines, decanters and related devicesfor infection control and fluid management. The design and development, manufacture and distribution of sterile and non-sterile disposable patient drapes, equipment covers, medical waste bags, high pressure lines, pressure monitoring lines, decanters and related devicesfor infection control and fluid management. The Design, Manufacture, Installation, Service and Distribution of In-Vitro Diagnostic Devices Used for Rapid Detection and Identification of Bacteria and Yeast in Blood Cultures. The contract assembly, plastic injection moulding, manufacture and packaging of non-sterile medical devices including guidewire and catheter dispensers The contract assembly, plastic injection moulding, manufacture and packaging of non-sterile medical devices including guidewire and catheter dispensers. CMDCAS & MD: The design, development and manufacture of Medical Devices and Systems for Systemic Diagnosis, treatment and drug delivery. The Design and Development, Manufacture, Service and Distribution of Autofluorescence Systems utilized in the Detection and Delineation of Parathyroid Tissue during Surgical Procedures. The Design, Manufacture and Service of Ultrasonic Transducers and Transceivers, Sensing Instrumentation and Signal Processing Electronics. The Design, Manufacture and Service of Ultrasonic Transducers and Transceivers, Sensing Instrumentation and Signal Processing Electronics.
ISO 9k scope:Manufacture, Contract Manufacture and Distribution of Osmometry Calibration Standards for the Medical Device Industry and Sanitization Products for the Agricultural Industry.ISO 13485 scope: Manufacture, Contract Manufacture and Distribution of Disinfecting, Cleaning Agents and Disifectant Indicator Solutions for the Medical Device Industry. The design, manufacture, and distribution of in-vitro diagnostic medical devices used to screen for the presence of drugs of abuse, cancer markers, cardiac markers and transmissible agents; and for fertility testing and pregnancy testing. The manufacture and distribution of orthotic devices The Design, Manufacture and Distribution of Specialty Operating Tables and Positioning Accessories for the Operating Room. The provision of practice & project management services and customer training to healthcare professionals The Design, Manufacture and Distribution of Implantable Ophthalmic Gases, Gas-filled Micro-Cylinders and Gas Delivery, Injection, and Insertion Components and Devices for Ophthalmic and Dermal Medical Applications.
The Manufacture of High Reliability Hermetic Glass to Metal Seal Packages for the Microelectronics Industry. Design, Engineering, Manufacture, Service of Gas Analyzers and Systems for Sulfur Plant Control, Natural Gas Processing, Distribution and Air Emission Monitoring. The Design, Manufacturing and Repair of Aerospace Instrumentation to Specifications Agreed Upon With Other AMETEK Organizations and Our Customers.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
AS19.4721/A
Secondary
Harleysville
PA
USA
AS 9100 - C
AMETEK Process Instruments
19.1717
Single
Newark
DE
USA
ISO 9001:2008
Ametek Process Instruments
19.1718
Single
Pittsburgh
PA
USA
ISO 9001:2015
MD19.8002
Single
Spring City
PA
USA
ISO 13485/CMDCAS
19.8107
Single
Etters
PA
USA
ISO 9001:2015
AS19.1412/A
Single
Nogales, Sonora
Mexico
Mexico
AS 9100 - C
AS19.1412
Single
Nashua
NH
USA
AS 9100 - D
Amphenol TCS
14.0224
Primary
Nashua
NH
USA
ISO 14001:2004
Amphenol TCS
14.0224/A
Secondary
Nashua
NH
USA
ISO 14001:2004
Amphenol TCS
14.8119
Single
Nashua
NH
Amphenol TCS de Mexico
19.8155
Single
Baja California
Amulet Technologies, LLC
19.4832
Single
Campbell
Anacapa Technologies, Inc
MD19.8014
Single
19.4558
AOTI Ltd
COMPANY AMETEK Power and Data Systems
AMICI, Incorporated Amphenol Amphenol Printed Circuit Board Technolog Amphenol Printed Circuits
Scope The design and manufacture of aerospace instrumentation to specifications agreed upon with other Ametek organizations and our customers The design, manufacture and service of gas and liquid process instruments and instrument systems for industrial and laboratory applications. The design, manufacture and service of gas and liquid process instruments and instrument systems for industrial and laboratory applications. Design, Manufacture and Distribution of Breathing Circuit Assemblies Including: Aerosol Systems, Mask Kits, Tubing, Mouth Pieces, Connectors and Filters Design and Manufacturing of Interconnection Devices and High Speed Cables Manufacture of high technology backplanes, daughter cards, flex and rigid flex printed circuits and value added assembly services for aerospace, military and commercial applications. Design and manufacture of high technology backplanes, daughter cards, flex, and rigid flex printed circuits and value added assembly services for aerospace, military and commercial applications.
USA
ISO 14001:2015
Mexico
ISO 9001:2015
The design and manufacturing of backplane systems, high speed cables and high speed, high density connector components and assemblies. The design and manufacturing of backplane systems, high speed cables and high speed, high density connector components and assemblies. Design, Prototype and Pilot Manufacture of Backplane Systems, High Speed Cables and High Speed, High Density Connectors, Components and Assemblies High tech backplane assembly, connectors and cables
CA
USA
ISO 9001:2008
The design of high performance embedded Graphical User Interface (GUI) solutions for microcontroller based products.
San Dimas
CA
USA
ISO 13485/CMDCAS
Single
Orange Park
FL
USA
ISO 9001:2008
MD19.3979
Single
Co. Galway
Ireland
I.S.EN ISO13485:2012
Apollo Renal Therapeutics, LLC also
MD19.4936
Single
Ocala
FL
USA
ISO 13485:2003
Applied Science, Inc
MD19.4647
Single
Grass Valley
CA
USA
I.S.EN ISO13485:2012
APS Materials Inc
MD19.3932
Single
Co. Waterford
Ireland
I.S.EN ISO13485:2012
AQF Limited
MD19.0860
Single
Co. Meath
Ireland
I.S.EN ISO13485:2012
Aquilant Specialist Healthcare Services
19.5546
Single
Clondalkin, Dublin 22
Ireland
ISO 9001:2008
ARC Technology Solutions, LLC
19.4751
Single
Nashua
USA
ISO 9001:2008
Arcadyan Technology Corp.
TL19.4628
Single
Hsinchu City
Taiwan, R.O.C.
TL 9000 R5.5/R5.0
Associates of Cape Cod, Inc.
MD19.3017/A
Secondary
East Falmouth
MA
USA
ISO 13485/CMDCAS
Associates of Cape Cod, Inc.
MD19.3017
Primary
East Falmouth
MA
USA
ISO 13485/CMDCAS
19.4956
Single
Cuyahoga Falls
OH
USA
ISO 9001:2008
ATD emolda
MD19.5465
Single
Co Meath
Ireland
I.S.EN ISO13485:2012
Austin 3-1-1
19.8089
Single
Austin
TX
USA
ISO 9001:2015
Contact Center for the Provision of City Department Information and Services Offered to the Public
Austin Energy Customer Care
19.4562
Primary
Austin
TX
USA
ISO 9001:2015
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer payments, and managing customer accounts.
Austin Energy Customer Care
19.4562/A
Secondary
Austin
TX
USA
ISO 9001:2015
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer payments, and managing customer accounts.
Austin Energy Customer Care
19.4562/B
Secondary
Austin
TX
USA
ISO 9001:2015
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer payments, and managing customer accounts.
Austin Energy Customer Care
19.4562/D
Secondary
Austin
TX
USA
ISO 9001:2015
The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer payments, and managing customer
Andromeda Systems Incorporated
ATA Tools Inc
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
NH
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The Design and Development, Manufacture and Distribution of Antimicrobial Cleansers, Hydrogels, and Silver Products used for Skin and Wound Care. Design and Service Provider of Engineering, Maintenance and Logistics, Information Technology, Program Management, Acquisition Support and Financial Services to include any other Associated Services to Commercial and Government Enterprises. The Design, Manufacture and Distribution of Oxygen Therapy Systems. MD Scope: Manufacture, Assembly, and Packaging of Custom Injection Molded Products and Finished Devices for the Medical Industry.ISO9K Scope: Manufacture, Assembly, and Packaging of Custom Injection Molded Products and Finished Goods for the Medical, Commerical, and Defense Industries. The Manufacture and Distribution of Electronic Blood Collection and Mixing Systems. The manufacture and application of Thermal Spray Coating Solutions for the Bio-Medical and other industries.ISO 9k:The manufacture and application of Thermal Spray Coating Solutions for the Bio-Medical and other industries MD Scope: The manufacture and distribution of foam components and products for the medical device industry.ISO9K Scope: The manufacture of flexible foam products and packaging material. The Sales, Distribution and Servicing of Medical & Surgical Devices and Other Healthcare Products for the Healthcare Industry. Provision of Electrical, Software and Test Engineering and Manufacturing Services for the Electronic Industry. ISO 9001:2008 Scope: Design and Distribution of Wireless Telecommunication Products.TL9000-H Scope: Design and Distribution of Wireless Telecommunication Products for the Following Product Category: 6.2.4 Digital Data Service Units. The Design, Manufacture and Distribution of Limulus Amebocyte Lysate (LAL) Reagents (including In-VitroRelated Materials and Equipment; Contract Testing for Endotoxin and Glucan. The Design, Manufacture and Distribution of Limulus Amebocyte Lysate (LAL) Reagents (including In-Vitro Diagnostic Medical Devices for the Analysis of (1-->3)-▀-D-Glucan to Support the Diagnosis of Invasive Fungal Disease) andRelated Materials and Equipment; Contract Testing for Endotoxin and Glucan. Manufacture of tungsten carbide burs and the distribution of air tools and abrasive products The manufacture and distribution of specialized adhesive-backed and die-cut components for the medical device industry.ISO 9K The manufacture of specialized adhesive-backed die-cut components.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Austin Energy Customer Care
19.4562/C
Secondary
Austin
TX
USA
ISO 9001:2015
Austin Energy Electric Austin Energy Electric Austin Energy Electric Austin Energy Electric
19.4319/D 19.4319/E 19.4319/B 19.4319/C
Primary Secondary Secondary Secondary
Austin Austin Austin Austin
TX TX TX TX
USA USA USA USA
ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015
Austin Energy Power Production & Energy
19.4731/B
Secondary
Austin
TX
USA
ISO 9001:2015
Austin Energy Power Production & Energy
19.4731/C
Secondary
Del Valle
TX
USA
ISO 9001:2015
Austin Energy Power Production & Energy
19.4731
Primary
Austin
TX
USA
ISO 9001:2015
Austin Energy Power Production & Energy
19.4731/A
Secondary
Austin
TX
USA
ISO 9001:2015
Avenue Mould Solutions Ltd
MD19.3765
Single
Co. Sligo
Ireland
I.S.EN ISO13485:2012
The contract manufacture of injection moulded medical device components and the provision of validation services.
AVID Medical, Inc.
MD19.8071
Single
Toano
VA
USA
I.S.EN ISO13485:2012
The Manufacture and Distribution of Single Use Medical Device Convenience Trays and Surgical Sets, Needles and Accessories (sterile and non-sterile)
Azure MicroDynamics, Inc.
MD19.4251
Single
Lake Forest
CA
USA
I.S.EN ISO13485:2012
Contract Manufacturing of Non-Active Metal and Plastic Components and Subassemblies for Use in Medical Devices. The Manufacturing and Distribution of Medical Devices for Use in Orthodontics.
B. Braun Hospicare Limited
MD19.0173
Single
County Sligo
Ireland
I.S.EN ISO13485:2012
The design and manufacture of wound care products.
COMPANY
Service Delivery Service Delivery Service Delivery Service Delivery
B. Braun Medical Ltd.
Scope The provision of utility customer services including receiving customer requests, responding to customer requests, billing customers, processing customer payments, and managing customer accounts. System Maintenence & Restoration Calibration; Transformer Sets Distribution, Transmission, and Substation Services; Project Management; Complex Metering Distribution, Network and Illumination Services: Project Management; HVAC The processes for planning, procuring, producing and marketing electricity to retail customers, participants. The processes for planning, procuring, producing and marketing electricity to retail customers, participants. The processes for planning, procuring, producing and marketing electricity to retail customers, participants. The processes for planning, procuring, producing and marketing electricity to retail customers, participants.
ERCOT and wholesale market ERCOT and wholesale market ERCOT and wholesale market ERCOT and wholesale market
19.3563
Single
Dublin 12
Ireland
ISO 9001:2008
The Sales, Marketing, Distribution and after-sales support of pharmaceutical products, medical devices and equipment.
B. L. Industria Otica Ltda.
MD19.1858
Single
Brazil
Brazil
ISO 13485:2016
The manufacture and distribution of contact lenses.
Bariatec Corporation
MD19.8067
Single
Carson
USA
I.S.EN ISO13485:2012
The Design, Manufacture, and Distribution of Non-Active Implantable Annular Restriction Devices for use in Bariatric Surgery.
Bausch & Lomb - Iom Spa
MD19.1268
Single
Monza Brianza
Italy
I.S.EN ISO13485:2012
Bausch & Lomb Hastings
MD19.1854/F
Secondary
Hastings
East Susse
United Kingdom
I.S.EN ISO13485:2012
Bausch & Lomb Incorporated
MD19.1854/G
Secondary
Irvine
CA
USA
ISO 13485/CMDCAS
Bausch & Lomb Incorporated
MD19.1854/A
Secondary
Greenville
SC
USA
ISO 13485/CMDCAS
Bausch & Lomb Incorporated
MD19.1854/B
Secondary
Greenville
SC
USA
ISO 13485/CMDCAS
Bausch & Lomb Incorporated
MD19.1854/C
Secondary
Wilmington
MA
USA
ISO 13485/CMDCAS
Bausch & Lomb Incorporated
MD19.1854/D
Secondary
Clearwater
FL
USA
ISO 13485/CMDCAS
Bausch & Lomb Incorporated
MD19.1854
Primary
Rochester
NY
USA
ISO 13485/CMDCAS
MD19.1854/E
Secondary
Waterford
Ireland
ISO 13485/CMDCAS
Bayer Medical SRL
MD19.4991
Single
La Aurora de Heredia
Costa Rica
I.S.EN ISO13485:2012
Bayer Pharma AG
MD19.4968/B
Secondary
Leverkusen
Germany
I.S.EN ISO13485:2012
Bayer Pharma AG
MD19.4968
Primary
Berlin
Germany
I.S.EN ISO13485:2012
The design, manufacture and distribution of contact lens solutions. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. The Design and Development, Manufacture, and Distribution of Intraocular and Contact Lenses, Contact Lens Care Products and Accessories for Rinsing, Cleaning, Lubricating, Rewetting, and Storage of Contact Lenses.The Manufacture of Intraocular, Gas Permeable and Soft Lens Materials, and Over the Counter Eye Drop Products. Contract Irradiation Sterilisation in accordance with EN ISO 11137-1:2006. The Contract Manufacture of Sterile Intrafallopian Tube Implant and Delivery Systems The Design and Development, Manufacture and Distribution of Sterile Intrafallopian Tube Occlusion Inserts and Delivery Systems. The Design and Development, Manufacture and Distribution of Sterile Intrafallopian Tube Occlusion Inserts and Delivery Systems.
Bausch & Lomb Ireland
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
CA
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
BD Caribe Ltd.
MD19.1805
Single
Juncos
PR
Puerto Rico
I.S.EN ISO13485:2012
BD Medical
MD19.4253
Single
Franklin
WI
USA
I.S.EN ISO13485:2012
BD Medical - Diabetes Care
MD19.1436
Single
Holdrege
NE
USA
I.S.EN ISO13485:2012
The manufacture, packaging, sterilisation and contract sterilisation of drug delivery devices including syringes and pen needles, infusion sets, device components for assembly at other BD locations, and alcohol swabs.
BD Medical Surgical
MD19.2143
Single
Columbus
NE
USA
I.S.EN ISO13485:2012
ISO13485 & 9001:2008: The Manufacture of Sterile and Non-Sterile Hypodermic Needles, Syringes, Disinfecting Devices, and Components. The Manufacture of Saline and Heparin Pre-Filled Syringes for Irrigation.Irradiation Sterilization in Accordance with EN ISO 11137:2006 and Moist Heat Sterilization in Accordance with EN ISO 17665-1:2006.
BD Medical, Pharmaceutical Systems
MD19.2515X
Primary
Columbus
NE
USA
ISO 13485:2016
BD Medical, Pharmaceutical Systems
MD19.2515X/A
Secondary
Columbus
NE
USA
ISO 13485:2016
BD Medical, Pharmaceutical Systems
MD19.2515X/B
Secondary
Columbus
NE
USA
ISO 13485:2016
BE Peterson Inc.
19.4612
Single
Avon
MA
USA
ISO 9001:2015
Design and Manufacture of Heavy-Gauge Metal Parts, Equipment and ASME Code Tanks & Filtration Vessels for Power and Utilities, Medical, Chemical/Environmental/Filtration, and Other Industrial Applications
Beckman Coulter Ireland Inc.
14.0316
Single
Co. Clare
Ireland
ISO 14001:2004
The design, development, manufacture, supply and customer support of clinical chemistry and heterogenous immunoassay invitro diagnostic devices
Becton Dickinson and Company
14.0398
Single
Co. Louth
Ireland
ISO 14001:2004
The manufacture of blood lancets, sterile and non sterile hypodermic needles and syringes and needle components for syringes
Becton Dickinson and Company, BD Medical
MD19.4912
Single
Franklin Lakes
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company
MD19.1385
Single
Co. Dublin
Ireland
I.S.EN ISO13485:2012
Becton, Dickinson and Company
MD19.2305
Single
Franklin Lakes
NJ
USA
ISO 13485/CMDCAS
Becton, Dickinson and Company
MD19.2369
Single
Canaan
CT
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company (BD)
MD19.1714
Primary
Sumter
SC
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company (BD)
MD19.2017
Single
Broken Bow
NE
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company (BD)
MD19.2137
Single
Franklin Lakes
NJ
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company (BD)
MD19.1714/A
Secondary
Sumter
SC
USA
I.S.EN ISO13485:2012
Becton, Dickinson and Company Limited
MD19.1609
Single
Co. Louth
Ireland
I.S.EN ISO13485:2012
Becton, Dickinson and Company Limited
MD19.5231
Single
Co. Dublin
Ireland
ISO 13485/CMDCAS
Bellurgan Precision Engineering Ltd
MD19.8037
Single
Co Louth
Ireland
I.S.EN ISO13485:2012
Bemis Healthcare Packaging Ireland
MD19.2163
Single
Co. Offaly
Ireland
I.S.EN ISO13485:2012
Bern Optics, Inc
COMPANY
NJ
MD19.4835
Single
Westfield
MA
USA
I.S.EN ISO13485:2012
Bijur Delimon International
19.4018
Single
Kinston
NC
USA
ISO 9001:2015
Bio Medical Research, Ltd
MD19.1000
Single
Co. Galway
Ireland
I.S.EN ISO13485:2012
BioCheck, Inc.
MD19.3666
Single
Foster City
USA
I.S.EN ISO13485:2012
Biolab Equipment Ltd.
MD19.4438
Single
Burlington, Ontario
Canada
ISO 13485/CMDCAS
Biomnis Ireland (Logistics Division)
19.5358
Single
Dublin 18
Ireland
ISO 9001:2015
BIOO Scientific
19.8127
Single
Austin
USA
ISO 9001:2008
MD19.8066/B
Secondary
2182 DZ Hillegom
The Netherlands
EN ISO 13485:2012
Biosensors B.V. (BBV) ** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
CA
TX
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope MD & ISO9K Scope: The manufacture of sterile and non-sterile, single use devices including specialty needles (epidural, spinal, biopsy), safety needle, chest drain valve, bladder drain catheter, catheter adapter and accessories,micro-collection, specimen collection, blood transfer and lancets. The manufacture, packaging and distribution of pre-filled sterile flush syringes
The Manufacture of Pre-fillable, Drug Delivery Components. In-house Ethylene Oxide Sterilization in Accordance with ISO 11135:2007. The Manufacture of Pre-fillable, Drug Delivery Components. In-house Ethylene Oxide Sterilization in Accordance with ISO 11135:2007. The Manufacture of Pre-fillable, Drug Delivery Components. In-house Ethylene Oxide Sterilization in Accordance with ISO 11135:2007.
The Manufacture and Distribution of Diabetes Drug Delivery Syringes, Diabetes Drug Delivery Safety Pen Needles, Diabetes Drug Delivery Pen Needles and Lancets. The Manufacture, Packaging and Sterilization of Insulin Delivery Systems. MD/CM Scope: The Design, Manufacture and Distribution of Sterile and Non-Sterile Needles, Syringes, Pre-Filled Syringes, Needleless Access Devices, Catheters and Catheter Accessories forVascular Access, Drainage, Infusion and Epidural use, Anesthesia, Radiology and Biopsy Kits, Trays and Accessories, and Closed System Transfer Devices. (ISO9K ending only: Specialty Plastic Containers for the Collection and Transport of HealthcareWaste.) The Manufacture of Sterile and Non-Sterile, High and Low Volume Hypodermic Syringes, Syringe Components and IV Cannula Products. The manufacture, molding and irradation sterilization of disposable medical devices for use in blood collection and laboratory services. The molding and manufacture of sterile and non-sterile blood collection devices, urine collection devices, cell preparation tubes, anaerobic specimen collection devices and needle holders. The provision of intra-company label printing and irradiationsterilization services in accordance with ISO 11137. The Design and Development, Manufacture and Distribution of preanalytical products including sterile and non-sterile blood / urine collection devices, sterile cell preparation devices, anaerobic specimen collectiondevices, venting unit sub-assemblies, blood collection needles, administration sets, microcollection devices and lancets. The manufacture, molding and irradation sterilization of disposable medical devices for use in blood collection and laboratory services. The manufacture and distribution of blood lancets, insulin delivery system accessories, sterile and non-sterile hypodermic needles and syringes, prefilled syringes and components for syringes. The manufacture and distribution of medical devices for drug transfer, medical components, non-active medical devices and diagnostic products. The manufacture of precision machined components for the medical device industry. The manufacture and supply of both sterile and non-sterile packaging products, contract packaging and assembly of medical devices for the healthcare industry. The manufacture and distribution of optical components and assemblies for medical device equipment and instrument applications. The Design, Manufacture and Distribution of Lubrication Systems and Components. The design, maufacture and distribution of powered stimulators, electrodes, and lead wires for the Urology, Neurology and Physical Medicine areas. The design, manufacture and distribution of ELISA test kits for Tumor markers, cardiac markers, hormone, fertility, TORCH, infectious disease, other analytes (IgE and Ferritin) and contract development and manufacturing. Design, Manufacturing, Installation and Service of Water Purification System for Medical Applications.9k scope: Design, Contract Development, Manufacturing, Installation and Service of Water Purification System for Industrial, Commercial and Pharmaceutical Applications. Transportation of pathological specimens to Healthcare Settings Develops & Manufactures Bio Products for Food & Feed Safety & for Research Purposes, which include Products for Detecting Animal Diseases, Antibiotics, Contaminants, Hormones, Microbiology/Hygiene and Toxins. The Design, Manufacture & Distribution of the BioMatrix Alpha Drug-Eluting Coronary Stent (DES), and Associated Catheters and Delivery Systems.
01/18/18
Registration Number
Profile Type
MD19.8066
Biosensors Interventional Technologies BioTek Instruments GmbH
COMPANY
Country
Scheme
Primary
Switzerland
I.S.EN ISO13485:2012
MD19.8066/A
Secondary
Singapore
EN ISO 13485:2012
MD19.2126/A
Secondary
Bad Friedrichshall
Germany
I.S.EN ISO13485:2012
ISO13485 : The Design, Manufacture, Distribution, Service and Installation of in-vitro diagnostic Microplate Readers, Washers, Dispensers, Stackers, Pipetting Work Stations and Accessories.
BioTek Instruments, Inc
MD19.2126
Primary
Winooski
VT
USA
I.S.EN ISO13485:2012
ISO 13485 Scope: The Design, Manufacture, Distribution, Service and Installation of in-vitro diagnostic Microplate Readers, Washers, Dispensers, Stackers, Pipetting Work Stations and Accessories.ISO9001: The design, manufacture, distribution, service and installation of research and development and in-vitro diagnostic products.
Blue Spark Technologies Inc
MD19.8114
Single
Cleveland
OH
USA
I.S.EN ISO13485:2012
The Design, Manufacture, and Distribution of Single-Use, Wireless Thermometers, including Associated Software.
19.4595
Single
Bowling Green
KY
USA
ISO 9001:2008
Boekel Scientific
MD19.4426
Single
Feasterville
PA
USA
I.S.EN ISO13485:2012
Bon Secours Hospital
MD19.5448
Single
Co. Galway
Ireland
ISO 13485:2016
The provision of quality inspection, sorting, containment, rework, and manufacturing support services to commercial and automotive manufacturers and distributors. ISO 13485 Scope: The Design, Manufacture and Distribution of Active Blood Storage and Thawing Devices.9K Scope: The Design, Manufacture and Distribution of Life Science and General Laboratory Equipment Servicing the Medical, Pharmaceutical, Biotech and Life Science Markets. The Provision of Disinfection and Sterilisation Services for Re-usable Invasive Medical Devices.
Bonding Source
19.4854
Single
Manchester
USA
ISO 9001:2008
Value Added Re-Seller of Epoxies and Related items for the Microelectronics and RF/Microwave Industries
Borchers sas
19.4885
Single
Castres
France
ISO 9001:2008
Development, Production, Sale of Additives for Paints, Varnishes, Adhesives, Polyester and Printing Inks.Developpement, Fabrication, vente et negoce dÆadditif pour peintures, vernis, colles; polyester et encres d'imprimerie.
Borchers sas
14.4885
Single
Castres
France
ISO 14001:2004
Development, Production, Sale of Additives for Paints, Varnishes, Adhesives, Polyester and Printing Inks.Developpement, Fabrication, vente et negoce dÆadditif pour peintures, vernis, colles; polyester et encres d'imprimerie.
Borchers sas
18.4885
Single
Castres
France
BS OHSAS 18001:2007
Development, Production, Sale of Additives for Paints, Varnishes, Adhesives, Polyester and Printing InksDeveloppement, Fabrication, vente et negoce dÆadditif pour peintures, vernis, colles; polyester et encres d'imprimerie.
Boston Sight
MD19.4929
Single
Needham
MA
USA
IS EN ISO 13485:2012
Design, Manufacture, Distribution and Servicing of Custom Machined, Special Purpose Contact Lenses
19.4833
Single
Bow
NH
USA
ISO 9001:2008
MD19.4741
Single
Lee
MA
USA
I.S.EN ISO13485:2012
Biosensors Europe SA
Bluegrass Supply Chain Services
Bovie Screen Process Printing Co., Inc. Boyd Technologies, Inc.
CITY
STATE
NH
Scope The Design, Manufacture & Distribution of the BioMatrix Alpha Drug-Eluting Coronary Stent (DES), and Associated Catheters and Delivery Systems. The Design, Manufacture & Distribution of the BioMatrix Alpha Drug-Eluting Coronary Stent (DES), and Associated Catheters and Delivery Systems.
The Provision of Manufactured Printed Products such as Membrane Switches, Overlays, Decals, Labels and Direct Product Markings. MD Scope: The Manufacturing, Converting, Assembly, Packaging, and Distribution of Advanced Flexible Materials for the Medical Device Industry.ISO9K Scope: The Manufacturing, Converting, Packaging, and Distribution of Advanced Flexible Rollto-Roll Materials. Motor carrier transportation of shipments that require extensive safety and security Design and Manufacture of Electrical and Fiber Optic Connectors, Cable Assemblies and System Solutions for Harsh Subsea Environments for Military and Commercial Applications. Conversion and Distribution of High Performance Films, Foils and Tapes
Boyle Transportation
19.4254
Single
Billerica
MA
USA
ISO 9001:2008
Brantner & Associates, Inc.
19.4706
Primary
El Cajon
CA
USA
ISO 9001:2015
Bristol Tape Corporation
19.4245
Single
Fall River
MA
USA
ISO 9001:2008
MD19.3331
Single
Co. Galway
Ireland
ISO 13485/CMDCAS
Broadcast Microwave Services, Inc.
19.463
Single
Poway
CA
USA
ISO 9001:2008
Design and Manufacture of Microwave Communications Equipment for the Television Broadcast, Surveillance, Homeland Security and Law Enforcement Industries.
Buckshot Vapors, Inc.
19.8076
Single
Costa Mesa
CA
USA
ISO 9001:2015
Design, development, manufacture and distribution of e-liquids containing nicotine for use in electronic cigarettes.
BWT Pharma & Biotech Ltd.
19.5228
Single
Dublin
Ireland
ISO 9001:2008
The Design, Manufacture, Installation, Commissioning and Servicing of Water Purification Systems.
Calex Manufacturing Co., Inc.
19.191
Single
Concord
CA
USA
ISO 9001:2015
The design, manufacture and sales of DC/DC, AC/DC Power Conversion Products, Instrumentation Products and LED Drivers
Caliper Life Sciences, Inc.
MD19.4724
Primary
Hopkinton
MA
USA
I.S.EN ISO13485:2012
Caliper Life Sciences, Inc.
MD19.4724/B
Secondary
Hopkinton
MA
USA
I.S.EN ISO13485:2012
19.4561
Single
Arlington
VA
USA
ISO 9001:2015
Cambridge Isotope Laboratories, Inc.
MD19.4654
Secondary
Andover
MA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference Material for use in Screening, Diagnosis and Monitoring of Metabolic Disorders including Phenylketonuria.
Cambridge Isotope Laboratories, Inc.
MD19.4654/A
Primary
Tewksbury
MA
USA
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of Neonatal Standard Reference Material for use in Screening, Diagnosis and Monitoring of Metabolic Disorders including Phenylketonuria.
MD19.4497
Single
Newport Beach
CA
USA
ISO 13485/CMDCAS
19.4859
Single
Milroy
IN
USA
ISO 9001:2008
Brivant Limited
Cambridge International Systems, Inc.
Candelis, Inc. Cannon Fabrication Company
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
CMDCAS & MD Scope: The design, manufacture & distribution of interventional guide wires and components. The coating and packaging of sterile and non-sterile interventional devices including catheters.
The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of DNA fragments for diagnosis of disease, infection and abnormalities. The Design, Manufacture and Distribution of In-Vitro Diagnostic Systems for evaluation of DNA fragments for diagnosis of disease, infection and abnormalities. Design and Provisioning of National Security and Defense Services
The Design, Manufacture and Distribution of Picture Archiving and Communications Systems (PACS), Radiology Information Systems (RIS), RT, Radiology and Mammography Viewers. The manufacture of sound deadening products, die cut parts and assemblies.
01/18/18
COMPANY Cappoquin Logistics
Caragh Precision Cardinal Manufacturing Company
Registration Number
Profile Type
CITY
27.8116
Single
MD19.1029
STATE
Country
Scheme
Scope
Co. Waterford
Ireland
ISO 27001:2013
The ISMS applies to the provision of document storage services and the transportation of documents at Cappoquin Logistics, IDA Industrial EstateClogherane Dungarvan Co Waterford in accordance with the Statement of Applicability Version 3.0, dated May 11, 2017
Single
Galway
Ireland
I.S.EN ISO13485:2012
19.4596
Single
Louisville
KY
USA
ISO 9001:2015
MD19.4290/A
Single
Roseville
CA
USA
I.S.EN ISO13485:2012
Carlsbad International Export Inc. Carolina Laser Cutting Inc.
MD19.4310 19.453
Single Single
Carlsbad Greensboro
CA NC
USA USA
I.S.EN ISO13485:2012 ISO 9001:2008
CASWELL, INC.
TL19.4777
Single
New Taipei City
Taiwan
TL 9000 R5.5/R5.0
Celestica Ireland Ltd.
MD19.5453
Single
Co. Kildare
Ireland
I.S.EN ISO13485:2012
Cellmic, LLC
MD19.4901
Single
Los Angeles
19.3763
Single
Co Limerick
Charles Industries, Ltd.
TL19.4427
Primary
Rolling Meadows
Charles Industries, Ltd.
TL19.4427/A
Secondary
Charles Industries, Ltd.
TL19.4427/B
Charles Industries, Ltd. Charles Industries, Ltd.
Care Innovations LLC
CervicalCheck
Charter Medical Ltd CHD Bioscience, Inc. CHD Bioscience, Inc. Chromatics, Inc. Circit Limited Circuit Technology, Inc
CA
MD Scope: The manufacture of precision machined components and products for medical devices including passivation, cleaning and cleanroom manufacturing.ISO9K Scope: The manufacture of precision machined components. The Design and Manufacture of Roll Formed custom products. The Design, Development, Manufacturing and Distribution, and Service of Health Information Systems to Aggregate and Transmit Data for Patient Care Management Manufacture and Distribution of Consumable Medical Accessories for Ventilation Products. The provision of high precision CO2 laser cutting and sheet metal fabrication services. ISO 9001 Scope: Manufacture, Design and Sales of Server, Network Related Server and M/B & NIC.TL 9000-H Scope: Manufacture, Design and Sales of Server, Network Related Server and M/B & NIC for the Product Category: 8.2.3-High Complexity Electronic Assemblies. The Contract Manufacture of Medical Device Assemblies The Design, Manufacture, and Distribution of hand-held In-Vitro Diagnostic Test Systems for Lateral Flow Immunoassay Testing. The management of the National Cervical Screening Programme The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures. The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures. The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures. The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures. The design, manufacture and sale of telecommunications, CATV and marine and industrial products.TL9000-H for the following hardware product category: 3.1.2.1 Enclosures.
USA
I.S.EN ISO13485:2012
Ireland
ISO 9001:2015
IL
USA
TL 9000 R5.5/R5.0
Canton
MO
USA
TL 9000 R5.5/R5.0
Secondary
Casey
IL
USA
TL 9000 R5.5/R5.0
TL19.4427/C
Secondary
Marshall
IL
USA
TL 9000 R5.5/R5.0
TL19.4427/D
Secondary
Rantoul
IL
USA
TL 9000 R5.5/R5.0
MD19.4307
Single
Winston Salem
NC
USA
I.S.EN ISO13485:2012
The design, manufacture and distribution of Medical Devices used in collection, storage and processing of blood and blood components to include tubing, connectors, syringes, mesh filters and bags.The manufacture and distribution of foam, felt and knit components for medical applications.The design, manufacture and distribution of disposable bio-containers.
MD19.8038 MD19.8038/A 19.254
Primary Secondary Secondary
Fort Collins Fort Collins Bethel
CO CO CT
USA USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 ISO 9001:2015
The Design of Orthopaedic Implants with an Antimicrobial and Lubricious Coating The Design of Orthopaedic Implants with an Antimicrobial and Lubricious Coating The Design, Sales and Manufacture of Fluoropolymer Color Concentrates and Compounds
27.8102
Single
Dublin 1
Ireland
ISO 27001:2013
The ISMS applies to the information assets and processes that arise out of the provision of software services from its office at NCI Business Centre, IFSC, Dublin 1, Ireland in accordance with the Statement of Applicability Version 46. Sales and Production of Electronic Assemblies
19.4689
Single
Merrimack
NH
USA
ISO 9001:2015
ClearFlow, Inc.
MD19.4770
Single
Anaheim
CA
USA
I.S.EN ISO13485:2012
Cliniqa Corporation
MD19.3440
Primary
San Marcos
CA
USA
ISO 13485/CMDCAS
Cliniqa Corporation
MD19.3440/A
Secondary
San Marcos
CA
USA
ISO 13485/CMDCAS
Coatings 2 Go, LLC
MD19.4810
Single
Carlisle
MA
USA
I.S.EN ISO13485:2012
19.1521
Single
San Diego
CA
USA
ISO 9001:2015
Cokiya Inc. Colorant Chromatics Ab
MD19.4963 19.2540/C
Single Primary
San Diego Aland
CA
USA Finland
I.S.EN ISO13485:2012 ISO 9001:2015
Colorant Chromatics Europe B.V.
19.2540/B
Secondary
The Netherlands
ISO 9001:2015
Colorant GmbH
19.2540/A
Secondary
Limburg-Offheim
Germany
ISO 9001:2015
Combe Laboratories Inc.
MD19.4791
Single
Rantoul
IL
USA
ISO 13485:2003
Computer Cite (CCITE)
19.4493
Single
San Ramon
CA
USA
ISO 9001:2015
The Design and Development, Manufacture, Service and Distribution of Surgical Gamma Probe The Design, Sales and Manufacture of Fluoropolymer Color Concentrates and Compounds Sales and Distribution of Color Concentrates and Compounds for Processing of Fluoropolymers andHigh Temperature Engineering Thermoplastics Sales and Distribution of Color Concentrates and Compounds for Processing of Fluoropolymers andHigh Temperature Engineering Thermoplastics Manufacturing of denture adhesive seals, feminine wipes, and feminine intimate health products including lubricants for vaginal use.Fabricante de almohadillas adhesivas para dentadura postiza, toallas femeninas, y productos para la salud intima femenina, incluidos los lubricantes para uso vaginal Provision of contract staffing services and special project services.
Comtran Cable, LLC
19.4288
Single
South Attleboro
MA
USA
ISO 9001:2015
Design and Manufacture of Wire and Cable for Electrical, and Voice and Data Communications Applications.
Confluent Medical Technologies Inc.
MD19.4908
Primary
Warwick
RI
USA
ISO 13485:2003
Confluent Medical Technologies Inc.
MD19.4909
Primary
Sunnyvale
CA
USA
ISO 13485:2003
CohuHD Costar, LLC.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The design, manufacture and distribution of sterile, disposable chest drainage catheters and systems. The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw materials, reagents and kits for the diagnosis, management, detection of blood analytes, blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse. The design, development and manufacture of in-vitro diagnostic controls, calibrators, raw materials, reagents and kits for the diagnosis, management, detection of blood analytes, blood components, cardiac markers, cancer, therapeutic drug monitoring,and drugs of abuse. The Manufacture and Distribution of Coatings for use in the Medical Device Industry. The Research, Design, Manufacture, Distribution, and Servicing of Cameras, Advanced Video Products and Systems.
The Contract Design, Development, and Manufacture of Textile and Composite Materials for the Biomedical, Biosurgical and Tissue Engineering Markets Design, Development and Manufacturing of Polymer Based Components and Assemblies for Medical Device and Diagnostic Applications
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
MD19.4908/A
Secondary
Warwick
RI
USA
ISO 13485:2003
Consortia Development, Inc. Contech Medical, Inc.
MD19.8072 MD19.2616
Single Single
Reno Providence
NV RI
USA USA
ISO 13485:2003 I.S.EN ISO13485:2012
Controls for Automation
MD19.4820
Primary
Taunton
MA
USA
I.S.EN ISO13485:2012
Conventus Orthopaedics, Inc
MD19.4600
Single
Maple Grove
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture and Distribution of Non-Active Orthopaedic Implants and Associated Accessories.
Corbin Clinical Resources
MD19.8081
Single
Cumberland
MD
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of Transperineal Access Systems for use during Prostate Biopsy.
Core Sound Imaging, Inc.
MD19.4618
Single
Raleigh
NC
USA
I.S.EN ISO13485:2012
19.4701
Single
Greensboro
NC
USA
ISO 9001:2015
Corfin Industries LLC
AS19.4267
Single
Salem
NH
USA
AS 9100 - D
Corning Incorporated
MD19.8019
Single
Mexico
I.S.EN ISO13485:2012
ISO 9001:The design, manufacture and distribution of sterile and non-sterile fluid handling products, tissue culture products, and the manufacture, distribution and servicing of electrical laboratory products.ISO 13485: The design, manufacture and distribution of sterile fluid handling products, tissue culture products, and general IVD products.
Corning Incorporated
MD19.2294
Single
Durham
NC
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products.
Corning Incorporated- Life Sciences Corning Incorporated- Life Sciences, Corning Incorporated- Life Sciences, Corning Incorporated- Life Sciences, Corning Life Sciences
14.4942 19.2788 19.2788/A 14.4942/A 14.4847
Primary Primary Secondary Secondary Single
Bedford Bedford Woburn Woburn Durham
MA MA MA MA NC
USA USA USA USA USA
ISO 14001:2004 ISO 9001:2015 ISO 9001:2015 ISO 14001:2004 ISO 14001:2004
CorTechs Labs, Inc
MD19.4998
Single
San Diego
CA
USA
I.S.EN ISO13485:2012
Cosman Medical, LLC
MD19.4004
Single
Burlington
MA
USA
I.S.EN ISO13485:2012
Craft Translation, LLC Craft Worldwide Craft Worldwide Craftech Industries, Inc.
19.8001 19.8000/A 19.8 19.4545
Single Secondary Primary Single
New York Mumbai New York Hudson
NY NY NY
USA India USA USA
ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008
Creation Technologies
MD19.3514/B
Single
Milpitas
CA
USA
I.S.EN ISO13485:2012
Creation Technologies
AS19.8052
Single
Milpitas
CA
USA
AS 9100 - C
COMPANY Confluent Medical Technologies Inc.
Core Technology Molding Corp
CRI-SIL Silicone Technologies, LLC
Scope The Contract Design, Development, and Manufacture of Textile and Composite Materials for the Biomedical, Biosurgical and Tissue Engineering Markets Design, Manufacturing and Distribution of Single-Use and Re-Usable Orthopaedic Instruments. Contract Assembly and Packaging of OEM Medical Device Components and Assemblies. MD Scope: The manufacture and distribution of components and assemblies for the medical device industry.ISO9K Scope: The manufacture and distribution of components, manufactured products and assemblies for various industries that include medical.
The Design and Development and Distribution of Web-Based Picture Archival and Communications Systems (PACS), Including Software. The inspection, rework, assembly of secondary plastics and molding processes Trim, Form, BGA Reballing, J-Lead Attach, Lead Straightening, Lead Reconditioning, Solderability Testing, Fine & Gross Leak Testing, Ionic Cleanliness Testing, X-Ray Fluorescence Testing, Tape & Reel, Bake & Dry Packaging, Long Term Storage, Kitting,and Robotic Hot Solder Dip of Electronic Devices, Including Component Preparation and Termination Finish Conversion for RoHS Compliance, and the Elimination of Tin Whisker and Gold Embrittlement Risks.
The Design and Manufacture of Products for Research Use Only in Life Sciences Research The Design and Manufacture of Products for Research Use Only in Life Sciences Research. The Design and Manufacture of Products for Research Use Only in Life Sciences Research. The Design and Manufacture of Products for Research Use Only in Life Sciences Research Manufacture and Distribution of Sterile Fluid Handling and Tissue Culture Products. The Design and Development, Manufacture and Distribution of Aggregated Medical Device Software used for Volumetric Analysis of MR Images. The Design and Development, Manufacture, Servicing and Distribution of RF Lesion Generators and Associated Sterile and Non-Sterile RF Electrodes and Injection Needles for Surgical Use. Multilingual Translation Services Multimedia Advertising Services Multimedia Advertising Services Fabrication of high performance fasteners and components. Manufacturing of electronic printed circuit board assemblies and system integration of printed circuit board assemblies into finished electronic equipment. Manufacturing of Electronic Printed Circuit Board Assemblies and System Integration of Printed Circuit Board Assemblies into Finished Electronic Equipment. Manufacturer and Delivery of Performance Elastomer Products and Services
19.4393
Single
Biddeford
ME
USA
ISO 9001:2015
MD19.4575
Primary
San Diego
CA
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assays and Related Controls for Professional Use.
MD19.4575/A
Secondary
Dublin 18
Ireland
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of ST2 In-Vitro Diagnostic Assays and Related Controls for Professional Use.
Critical Process Filtration, Inc.
19.4734
Single
Nashua
Croom Precision Medical Ltd
MD19.1758
Single
Co. Limerick
CROSSTEX International, Inc.
MD19.4439/A
Secondary
Sharon
CROSSTEX International, Inc.
MD19.4439/B
Secondary
CROSSTEX International, Inc.
MD19.4439
Primary
Cruzar Medsystems, Inc.
MD19.8105
CTT, Inc.
AS19.3210 19.4154
Critical Care Diagnostics, Inc. Critical Diagnostics Limited
Cubbison Company
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
NH
USA
ISO 9001:2008
Ireland
I.S.EN ISO13485:2012
PA
USA
I.S.EN ISO13485:2012
Hauppauge
NY
USA
I.S.EN ISO13485:2012
Hauppauge
NY
USA
I.S.EN ISO13485:2012
Single
Braintree
MA
USA
I.S.EN ISO13485:2012
Single
San Jose
CA
USA
AS 9100 - C
Single
Youngstown
OH
USA
ISO 9001:2015
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Manufacture and Distribution of Filter Systems for diverse industries including Medical Devices. The manufacture of precision medical device components. The Design, Manufacture and Distribution of Face Masks, Examiniation Gloves, Non-Sterile" Single-Use Barrier Products Dental Waterline Treatment Products Sterilization Packaging and Accessories Dental Devices and Related Accessories for the"Healthcare Industry The Design, Manufacture and Distribution of Face Masks, Examiniation Gloves, Non-Sterile" Single-Use Barrier Products Dental Waterline Treatment Products Sterilization Packaging and Accessories Dental Devices and Related Accessories for the"Healthcare Industry The Design, Manufacture and Distribution of Face Masks, Examiniation Gloves, Non-Sterile" Single-Use Barrier Products Dental Waterline Treatment Products Sterilization Packaging and Accessories Dental Devices and Related Accessories for the"Healthcare Industry The Design, Manufacture, and Distribution of Sterile Catheters for Percutaneous Applications Design and manufacture of Microwave, LNA, Power Amplifiers, Frequency Converters, Frequency Multipliers, Transmitters, Transceivers and Subsystems. Design and Manufacture of Custom Product Identification Solutions (e.g. Cut Film Graphics, Domed Labels, Overlays, Label Kits, Industrial Labels, Metal Nameplates, Printed Electronics and Membrane Switches).
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
CVRx, Inc.
MD19.4838
Single
Minneapolis
MN
USA
I.S.EN ISO13485:2012
CWS-boco
MD19.3904
Single
Dublin 22
Ireland
I.S.EN ISO13485:2012
19.4839
Single
Bedford
MA
USA
ISO 9001:2015
CytoTest Inc.
MD19.4925
Single
Rockville
MD
USA
I.S.EN ISO13485:2012
Dadson Manufacturing Corporation
MD19.4429
Single
Grain Valley
MO
USA
I.S.EN ISO13485:2012
Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Trucks North America Daimler Vehφculos Comerciales
14.8012/B 14.8012/C 14.8012/D 14.8012/E 14.8012/F 14.8012/G 14.8012/H 14.8012/I 14.8012/J 14.8012/K 14.8012/A 14.8012 14.8012/L 14.8012/M 14.8012/N
Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Primary Secondary Secondary Secondary
Cleveland Gaffney Portland Gastonia St. Mount Holly High Point High Point High Point High Point High Point Portland Fort Mill High Point High Point
NC SC OR NC NC NC NC NC NC NC OR SC NC NC
USA USA USA USA USA USA USA USA USA USA USA USA USA USA Mexico
ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004 ISO 14001:2004
Dansac A/S
MD19.8043
Single
3480 Fredensborg
Denmark
I.S.EN ISO13485:2012
DASAN Zhone Solutions, Inc.
19.3252/A
Single
Seminole
FL
USA
ISO 9001:2015
Data Exchange Corp
MD19.1921
Single
Camarillo
CA
USA
I.S.EN ISO13485:2012
Data Exchange Europe Ltd
MD19.2755
Single
Dublin 17
Ireland
I.S.EN ISO13485:2012
Data Exchange Europe Ltd
14.0424
Single
Dublin 17
Ireland
Dayton Forging and Heat Treating Deco-Chem Inc
19.4884 19.4336
Single Single
Dayton Mishawaka
Delfi Medical Innovations Inc.
MD19.4754
Primary
Vancouver, BC
Canada
Delfi Medical Innovations Inc.
MD19.4754/A
Secondary
Burnaby, BC
Canada
COMPANY
Cytonome/ST, LLC
OH IN
USA USA
Scope CMDCAS Scope: The design, manufacture and distribution of implantable and external pulse generators, programmer / external systems, implantable and temporary electrode / leads, surgical tool kits, and accessory kits.MD Scope: The design, manufacture and distribution of implantable and external pulse generators, programmer / external systems, implantable and temporary electrode / leads, surgical tool kits, and accessory kits for the treatment of cardiovasculardisease The manufacture, packaging and distribution of sterile and non-sterile surgical supplies, gowns, wound dressings, drapes, including sterile procedure packs Design, Manufacture, Sales, and Service of Cell Purification Systems and Technologies for BioMedicine, BioIndustry and BioScience. MD and ISO9K Scope: The design, manufacture, and distribution of DNA fluorescence in situ hybridization (FISH) probes for the diagnosis of chromosomal abnormalities. Contract Manufacturing, Distribution, and Servicing of Active Medical Systems for Neurological Diagnostics, Active and NonActive Surgical Instruments for Plastic, Orthopedic, Thoracic and General Surgery. Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing of Class 3-8 Trucks, Buses and Recreational Vehicles Manufacturing and Assembling of Medium and Heavy Duty Trucks MD Scope: The Design, Manufacture and Distribution of Disposable Ostomy Devices and Associated Medical Supplies.9K Scope: The Design, Manufacture and Distribution of Disposable Ostomy Devices and Associated Medical Supplies. Manufacture and Service of Electronic Telecommunications Equipment MD Scope: The repair, exchange, sale and end of life support for electronic, computer, communications, medical equipment and components.ISO9K Scope: The repair, exchange, sale and end of life support for electronic, computer, and communication equipment and components. MD Scope: The service & repair of active medical imaging equipment.ISO9K Scope: The repair, exchange, sale and support of equipment as well as logistic services for the electronic, communication, medical and renewable energy industries.
The repair, exchange sale and support of equipment - as well as logistics services - for the electronic, communication, medical and renewable energy industries ISO 9001:2008 Forging, Heat Treating and Machining of Steel and Alloys ISO 9001:2015 Manufacture of Ink The Design, Development, Manufacture, and Servicing of Tourniquet Systems. The Design, Development, and Manufacture of I.S.EN ISO13485:2012 Sterile and Non-Sterile Tourniquet Cuffs. The Design, Development, Manufacture, and Servicing of Tourniquet Systems. The Design, Development, and Manufacture of I.S.EN ISO13485:2012 Sterile and Non-Sterile Tourniquet Cuffs. BS OHSAS 18001:2007 Manufacture of Computer Storage Products ISO 14001:2015
Dell
18.8108
Single
Franklin
MA
USA
Dell
19.8108/A1
Secondary
Hopkinton
MA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/A2
Secondary
Hopkinton
MA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/A3
Secondary
Hopkinton
MA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell Dell Dell
18.811 14.8108/A 14.8108
Single Secondary Primary
Apex Apex Franklin
NC NC MA
USA USA USA
Dell
19.8108
Primary
Hopkinton
MA
USA
ISO 9001:2015
Design, Manufacuture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/D
Secondary
St-Petersburg 199004
Russian Federation
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/G
Secondary
Apex
NC
USA
ISO 9001:2015
Manufacture of Computer Storage Products
Dell
19.8108/H
Secondary
Cambridge
MA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/I
Secondary
Pleasanton
CA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
BS OHSAS 18001:2007 Manufacture of Computer Storage Products ISO 14001:2015 Manufacture of Computer Storage Products ISO 14001:2015 Manufacture of Computer Storage Products
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Dell
19.8108/J
Secondary
Southborough
MA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/K
Secondary
Seattle
WA
USA
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/L
Secondary
Franklin
MA
USA
ISO 9001:2015
Manufacture of Computer Storage Products
Dell
19.8108/N
Secondary
Cairo, Egypt
Arab Republic of Egy
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell
19.8108/C
Secondary
Beer Sheva
Israel
ISO 9001:2015
Design, Manufacture, Servicing, Training and Customer Support of Computer Storage Products
Dell (Chengdu) Company Limited
19.5000/R3/NN
Secondary
Chengdu
China
ISO 9001:2015
Manufacture and Supply of Computers, and Associated Hardware and Software and Related Management Activities.
Dell (Chengdu) Company Limited
14.5000/R3/NN
Secondary
Chengdu
China
ISO 14001:2015
Manufacture and Supply of Computers, and Associated Hardware and Software and Related Management Activities.
Dell (Chengdu) Company Limited
18.5000/R3/NN
Secondary
Chengdu
China
Dell (China) Co. Ltd (CCC5)
19.5000/R3/U2
Secondary
Xiamen
China
ISO 9001:2015
Dell (China) Co. Ltd.
19.5000/R3/U
Secondary
Fujian
China
ISO 9001:2015
Dell (China) Co. Ltd.
18.5000/R3/U
Secondary
Fujian
China
Dell (China) Co. Ltd. (CCC2)
14.5000/R3/U
Secondary
Fujian
China
ISO 14001:2015
The manufacture and supply of computers, servers, storage and associated hardware and software.
Dell (China) Co., Ltd.
19.5000/R3/P
Secondary
Beijing
China
ISO 9001:2015
All Provisions of Customer Service, Support and Sales Operations for Computers, Technology Products and Solutions
Dell (China) Co., Ltd.
19.5000/R3/Q
Secondary
Dalian
China
ISO 9001:2015
Dell (China) Co., Ltd.
19.5000/R3/PP
Secondary
HaiDian District 100080
China
ISO 9001:2015
Dell (China) Company Limited
27.5000/R3/U
Secondary
Xiamen, Fujian 361011, P.R.
China
ISO 27001:2013
Dell (China) Company Limited
27.5000/R3/U2
Primary
Xiamen, Fujian 361015; P.R.
China
ISO 27001:2013
Dell (Taiwan) B.V.
19.5000/R3/V
Secondary
Taipei
Taiwan, R.O.C.
ISO 9001:2015
Dell (Xiamen) Co. Ltd.
18.5000/R3/T
Secondary
Fujian
China
Dell (Xiamen) Co. Ltd.
19.5000/R3/T
Secondary
Fujian
China
ISO 9001:2015
Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software, Related Activities and All Provisions of Sales, Sales Operations, Customer Service, Support, and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
Dell (Xiamen) Co. Ltd. (CCC4)
14.5000/R3/T
Secondary
Fujian
China
ISO 14001:2015
The manufacture and supply of computers, servers, storage and associated hardware and software.
Dell A/S
19.5000/R2/C
Secondary
Copenhagen
Denmark
ISO 9001:2015
Dell AB
19.5000/R2/U
Secondary
Solna
Sweden
ISO 9001:2015
Dell AS
19.5000/R2/O
Secondary
Oslo
Norway
ISO 9001:2015
Dell Australia Pty Limited
19.5000/R3/A
Secondary
Sydney, New South Wales
Australia
ISO 9001:2015
Dell B.V.
19.5000/R2/N
Secondary
AK Amsterdam
Netherlands
ISO 9001:2015
Dell Canada
19.5000/R1/Q
Secondary
North York, Ontario
Canada
ISO 9001:2015
Dell Commerce Systems (DCS) Dell Computadores do Brazil Ltda
19.5000/R1/Z 14.5000/R1/A
Secondary Secondary
Round Rock HortolΓndia, SP 13.184-654
USA Brazil
ISO 9001:2015 ISO 14001:2015
Dell Computadores do Brazil Ltda.
19.5000/R1/B
Secondary
Eldorado do Sul - CEP
Brazil
ISO 9001:2015
Dell Computadores do Brazil Ltda.
19.5000/R1/A
Secondary
HortolΓndia, SP 13.184-654
Brazil
ISO 9001:2015
Dell Computadores do Brazil Ltda.
18.5000/R1/A
Secondary
HortolΓndia, SP
Brazil
Dell Computer S.A. (Spain)
19.5000/R2/W
Secondary
Madrid
Spain
Dell Computers S.A. (South Africa)
19.5000/R2/T
Secondary
Johannesburg
South Africa
COMPANY
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
TX
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
BS OHSAS 18001:2007 Manufacture and Supply of Computers, and Associated Hardware and Software and Related Management Activities Sales, Sales Operations, Customer Service & Support and Supply of Computers, and Associated Hardware and Software Related Activities Manufacture and Supply of Computers, Server, Storage, Associated Hardware, Software, Related Activities and All Provisions of Sales, Sales Operations, Customer Service, Support, and Customer Care for Computers, Server, Storage, Technology Productsand Solutions.
BS OHSAS 18001:2007 The manufacture and supply of computers, servers, storage and associated hardware and software.
All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions Design of applications software for thin clients (virtual) and related software. Activities applicable to end-to-end services and solutions, encompassing customer support, configuration services and deployment services for customers in ChinaSoA Revision 6.0 19 June 2016 Activities applicable to end-to-end services and solutions, encompassing customer support, configuration services and deployment services for customers in ChinaSoA Revision 6.0 19 June 2016 The Design, Development, Customer Services and Supporting Functions of Computers and Technology Products and Services
BS OHSAS 18001:2007 The manufacture and supply of computers, servers, storage and associated hardware and software.
All Provisions of Customer Service and Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions Sales, Sales Operations, Customer Service and Support for a range of desktop, server and notebook computers and associated peripherals. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions Software design, development and support. The manufacture and supply of computers and technology products. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions Manufacture, Fulfillment, Delivery, Refurbishment of Computers, Technology Products, Services and SolutionsTranslation: Fabricaτπo, realizaτπo, entrega, restauraτπo de computadores, produtos tecnol≤gicos, serviτos e soluτ⌡es
BS OHSAS 18001:2007 The Manufacture and Supply of Computers and Technology Products. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions
01/18/18
Registration Number
Profile Type
CITY
19.5000/R3/BB
Secondary
Dell Corporation Ltd
19.5000/R2/X
Dell Corporation Ltd.
COMPANY
Country
Scheme
Bangkok
Thailand
ISO 9001:2015
Secondary
Bracknell, Berkshire
United Kingdom
ISO 9001:2015
19.5000/R2/R
Secondary
Glasgow
United Kingdom
ISO 9001:2015
Dell Global B.V (Singapore Branch)
MD19.4934
Single
Singapore
I.S.EN ISO13485:2012
Dell Global B.V. (Singapore Branch)
19.5000/R3/Z
Secondary
Singapore
ISO 9001:2015
Dell Global Business Center
19.5000/R3/M
Secondary
Penang
Malaysia
ISO 9001:2015
Dell Global Business Center Sdn Bhd Dell Global Business Center Sdn Bhd Dell Global Business Center Sdn Bhd
18.5000/R3/N 14.5000/R3/N 19.5000/R3/N
Secondary Secondary Secondary
Penang Penang Penang
Malaysia Malaysia Malaysia
Dell GmbH
19.5000/R2/H
Secondary
60549 Frankfurt am Main
Germany
Dell Halle GmbH
19.5000/R2/I
Secondary
Halle (Saale)
Germany
Dell Inc.
19.5000/R3/L
Secondary
Selangor Darul Ehsan
Malaysia
Dell Inc.
19.5000/R3/K
Secondary
Tokyo
Japan
Dell Inc.
19.5000/R2/J
Secondary
Dublin
Ireland
ISO 9001:2015
Dell Inc.
19.5000/R3/I
Secondary
Kanagawa
Japan
ISO 9001:2015
Dell Inc.
19.5000/R3/J
Secondary
Miyazaki
Japan
ISO 9001:2015
Dell Inc.
19.5000/R3/R
Secondary
Shanghai
China
ISO 9001:2015
Dell Inc.
19.5000/R2/F
Secondary
Saint Denis (Paris)
France
ISO 9001:2015
Dell Inc.
19.5000/R1/C
Secondary
Mexico City
Mexico
ISO 9001:2015
Dell Inc.
19.5000/R1/D
Secondary
Panama City
Panama
ISO 9001:2015
Dell Inc.
19.5000/R1/E
Secondary
Round Rock
TX
USA
ISO 9001:2015
The Design, Development, Manufacture, Delivery, Sales Operations, Fulfillment, Customer Service, and Supporting Functions of Computers and Technology Products, Services and Solutions
Dell Inc.
19.5000/R1/F
Secondary
Round Rock
TX
USA
ISO 9001:2015
All Provisions of Sales Operations and Customer Care for Computers, Technology Products and Solutions for Federal Systems.
Dell Inc.
14.5
Primary
Round Rock
TX
USA
ISO 14001:2015
The Development, Manufacture, Supply, and Takeback Services of Computers and Technology Products.
Dell Corporation (Thailand) Co., Ltd.
STATE
18.5
Primary
Round Rock
TX
USA
Dell Inc.
19.5000/R1/L
Secondary
Nashville
TN
USA
Dell Inc.
19.5
Primary
Round Rock
TX
USA
ISO 9001:2015
Dell Inc. Dell Inc.
14.5000/R1/S 14.5000/R1/EE
Secondary Secondary
Round Rock Round Rock
TX TX
USA USA
ISO 14001:2015 ISO 14001:2015
Dell Inc. (Compellent)
19.5000/R1/Y
Secondary
Eden Prairie
MN
USA
Dell Inc. (Compellent)
19.5000/R1/Y3
Secondary
Eden Prairie
MN
USA
Dell Inc. (Copilot)
19.5000/R1/Y2
Secondary
Edina
MN
USA
Dell International Inc. (Korea)
19.5000/R3/Y
Secondary
Seoul
Korea
Dell International Services Dell International Services Dell International Services
14.5000/R3/E 18.5000/R3/E 19.5000/R3/E
Secondary Secondary Secondary
Kancheepuram, Tamil Nadu Kancheepuram, Tamilnadu Tamil Nadu
India India India
Dell International Services India Pvt.
19.5000/R3/C
Secondary
Bangalore
India
Dell International Services India Pvt.
19.5000/R3/OO
Secondary
Bangalore û 560 066,
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
India
All Provisions of Customer Service and Support for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions The Design and Development, Distribution, Service, and Support of Computer Display Systems for Medical and Healthcare Applications. The Design, Development, Product Line Marketing, provision of Customer Service, Support and Sales Operations for Computers, Technology Products and Solutions. All Provisions of Customer Service, Support and Sales Operations for Computers, Technology Products and Solutions
BS OHSAS 18001:2007 The Manufacture and Supply of Computers and Technology Products. ISO 14001:2015 Manufacture and Supply of Computers and Technology Products ISO 9001:2015 Manufacture and Supply of Computers and Technology Products All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products ISO 9001:2015 and Solutions All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products ISO 9001:2015 and Solutions.
Dell Inc.
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
The Design, Development and Services and Solutions and Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales, Sales Operations and Customer Care for Computers, Technology Products and Solutions Sales, Sales Operations, Customer Service and Supporting Functions of Computers and Technology Products and Services All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
BS OHSAS 18001:2007 The Manufacture and Supply of Computers and Technology Products The Fulfillment & Delivery, Sales Operations, Customer Service, and Supporting Functions of Computers and Technology ISO 9001:2015 Products and Services The Design, Development, Manufacture, Procurement, Fulfillment, Delivery, Sales Operations, Customer Service, Take-Back & Recycling, Refurbishment and Supporting Functions of Computers, Technology Products, Services and Solutions
Global Product Development Global Takeback Services The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions. The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions. The Design, Development, Sales Operations, Support, Services and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions ISO 14001:2015 The Manufacture and Supply of Computers and Technology Products BS OHSAS 18001:2007 The Manufacture and Supply of Computers and Technology Products. ISO 9001:2015 The Manufacture and Supply of Computers and Technology Products. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions. ISO 9001:2015 Design of applications software for thin clients (virtual) and related software.
01/18/18
Registration Number
Profile Type
CITY
Dell International Services India,
19.5000/R3/F
Secondary
Dell International Services India,
19.5000/R3/G
Dell International Services India, Pvt. Dell International Services India, Pvt.
COMPANY
STATE
Country
Scheme
Haryana
India
ISO 9001:2015
All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions
Secondary
Telangana
India
ISO 9001:2015
All Provisions of Customer Service, Support, Sales and Customer Care for Computers, Technology Products and Solutions
19.5000/R1/T3 19.5000/R3/B
Secondary Secondary
Tamil Nadu
India India
ISO 9001:2015 ISO 9001:2015
Dell International Services Philippines,
19.5000/R3/O
Secondary
Bagumbayan, Quezon City
Philippines
Dell International Services S.R.L.
19.5000/R2/BB
Secondary
Bucharest
Romania
Dell Italian Services
19.5000/R2/L
Secondary
6 Milano
Italy
Dell Limerick
19.5000/R2/K
Secondary
Limerick
Ireland
Dell N.V.
19.5000/R2/A
Secondary
DELL Products (Poland) Sp. z o.o.
19.5000/R2/DD
Secondary
92-410 Lodz
Poland
Dell Products (Poland) Sp. z o.o. Dell Products (Poland) Sp. z o.o.
14.5000/R2/DD 18.5000/R2/DD
Secondary Secondary
Lodz 92-410 Lodz
Poland Poland
Dell S.A. (France)
19.5000/R2/E
Secondary
Montpellier - 34000
France
Dell s.r.o
19.5000/R2/S
Secondary
Bratislava
Slovak Republic
Dell SA
19.5000/R2/V
Secondary
1215 GenΦve 15
Switzerland
Dell SAS
19.5000/R2/M
Secondary
20270 Casablanca
Morocco
Dell Silicon Valley Design Center (SVDC) Dell Technology & Solutions Israel Ltd
19.5000/R1/JJ 19.5000/R2/Z
Secondary Secondary
Santa Clara Herzliya Pituach
CA
USA Israel
Dell Wyse
19.5000/R1/KK
Secondary
Santa Clara
CA
USA
ISO 9001:2015
Dell, Inc.
19.5000/R1/M
Secondary
Oklahoma City
OK
USA
ISO 9001:2015
Dell, Inc. Dell, Inc. Dell, Inc.
19.5000/R1/GG 19.5000/R1/K 19.5000/R1/HH
Secondary Secondary Secondary
Nashua Atlanta
NH GA
Costa Rica USA USA
ISO 9001:2015 ISO 9001:2015 ISO 9001:2015
Dentalpoint AG
MD19.4976
Primary
Spreitenbach 8957
Switzerland
I.S.EN ISO13485:2012
Design Partners
MD19.4930
Single
Co. Wicklow
Ireland
I.S.EN ISO13485:2012
Device Technologies, Inc.
AS19.4480
Single
Southborough
MA
USA
AS 9100 - D
DiabetOmics, Inc.
MD19.4957
Single
Hillsboro
OR
USA
I.S.EN ISO13485:2012
CA
Belgium
Scope
The design, development and supporting functions for networking products and services. The Design, Development and Supporting Functions Of Computers And Technology Products. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions ISO 9001:2015 The provision of infrastructure ITO services at the Bucharest Service Center All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and SolutionsIncorporates the Full Range of Dell Services, including: Systems and Applications Managment, Maintenance and ISO 9001:2015 Development; Technical and Business Consulting; Technical Assistance, Support, Service Desk and Call Center ManagmentProduct Support; Education and End User Support All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service and Support, Sales Operations and Customer Care for Computers, Technology Products ISO 9001:2015 and Solutions. The manufacture and supply of computer and related products and solutions in EMFP (European Manufacturing Facilty ISO 9001:2015 Poland) ISO 14001:2015 The manufacture and supply of computer and related products and solutions. BS OHSAS 18001:2007 The manufacture and supply of computer and related products and solutions. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions.Includes General Procurement and Finance Functions. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and ISO 9001:2015 Solutions ISO 9001:2015 The Design, Development and Supporting Functions for Networking Products and Services. ISO 9001:2015 The Design and Development of Storage Systems and Solutions The design of applications software, sales, marketing & service of thin clients and related software. All Provisions of Customer Service, Support, Sales Operations and Customer Care for Computers, Technology Products and Solutions Technical Support Research, Design and Development of Storage Systems and Supporting Functions. Providers of IT Managed Security and Consultancy Services The design, manufacture and distribution of endosseous dental implant systems and associated surgical tools, drills and dental cements. The Design of Mechanical and Electromechanical aspects of non-implantable instruments and single use devices. Designs, Develops, Manufactures and Distributes Electronic and Environmental Wire Protection, Enclosure Sealing, Cable Management Materials and Specialty Fastener Products and Assemblies, and Linear Polymer Dielectric Coating Services.
USA
ISO 9001:2008
The Design, Manufacture and Distribution of In-Vitro Diagnostics for the Determination of Gestational Diabetes and Preeclampsia. Manufacture of Labels for Packaging Industry
China
AS 9100 - D
The Manufacture of Relay Panel Printed Circuit Board Assemblies. Exclusions: Product Design and Development
NY
USA
ISO 9001:2008
Fitchburg
MA
USA
AS 9100 - D
Primary
Dayton
OH
USA
I.S.EN ISO13485:2012
MD19.4644/A
Secondary
West Chester
OH
USA
I.S.EN ISO13485:2012
Duke Energy Renewable Services
19.4548
Single
Canby
MN
USA
ISO 9001:2008
Dunn Industries, Inc.
19.2466
Single
Manchester
NH
USA
ISO 9001:2008
DuPont Nutrition USA, Inc
19.089
Single
Newark
DE
USA
ISO 9001:2008
Dolphin Press
19.4634
Single
South San Francisco
Dongguan WKK Electronics Co. LTD.
AS19.4387
Single
Guangdong Province,
DPS Advanced Technology Group
19.3078/3
Secondary
Albany
DRS Power Technology, Inc.
AS19.3539
Single
DRT Medical LLC
MD19.4644
DRT Medical LLC - Morris
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The provision of design, engineering, procurement, commissioning, qualification, construction and project management, education and training services, and contract services for the pharmaceutical, healthcare, chemical and manufacturing industries AS & ISO Scope: Design, Engineering and Manufacturing of Gas Turbine Packaging, Steam Turbine and Permanent Magnet Electric Motors and Generators for Naval, Marine, Military Vehicles, Oil, Gas and Power Generator Applications. Precision Machining and Manufacturing of Medical Implants, Instruments, Components, and Finished Devices for the Medical Industry. Precision Machining and Manufacturing of Medical Implants, Instruments, Components, and Finished Devices for the Medical Industry. The provision of technical services, including project operations and maintenance activities to the North American wind industry. The custom extrusion of precision small diameter thermoplastic tubing for the medical device industry and other exacting commercial applications. The Manufacture of Excipients for the Food and Pharmaceutical Industries, and Natural Color Additives for the Food Industry.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
MD19.4935
Single
Paso Robles
CA
USA
ISO 13485:2003
Eagle Stainless & Tube Fabrication, Inc
MD19.4424/A
Secondary
Franklin
MA
USA
I.S.EN ISO13485:2012
Distribution, Fabrication and Assembly of Metal and Plastic Components for the Medical Device Industry.
Eagle Stainless Tube & Fabrication, Inc.
MD19.4424
Primary
Franklin
MA
USA
I.S.EN ISO13485:2012
Distribution, Fabrication and Assembly of Metal and Plastic Components for the Medical Device Industry.
Eaton B-Line Business - Wright Line
19.4653
Single
Worcester
MA
USA
ISO 9001:2008
Eaton Corporation
19.0853
Primary
Raleigh
NC
USA
ISO 9001:2008
Eaton Power Quality Operations
19.0853/B
Secondary
Raleigh
NC
USA
ISO 9001:2008
Eaton Power Quality Operations
19.0853/C
Secondary
Youngsville
NC
USA
ISO 9001:2008
Eaton Power Quality Operations
19.0853/A
Secondary
Raleigh
NC
USA
ISO 9001:2008
EchoPixel Inc.
MD19.4943
Single
Mountain View
CA
USA
ISO 13485/CMDCAS
19.2968
Single
Salt Lake City
UT
USA
ISO 9001:2008
COMPANY Eagle Medical, Inc.
EDO Western Corporation
Scope The contract manufacture, assembly, packaging and sterilization of active and non-active medical devices and medical device components including provision of gas plasma hydrogen peroxide contract sterilization per ISO 14937.
Design, Manufacture, Distribute, Install and Service Consoles and Enclosures for Data Centers, Control Rooms, Network Operations Centers, 911 Dispatch Centers, and Professional Office Settings. The design, manufacture, delivery, telecommunications markets. The design, manufacture, delivery, telecommunications markets. The design, manufacture, delivery, telecommunications markets. The design, manufacture, delivery, telecommunications markets.
depot repair and support of power quality products and systems for the computer and depot repair and support of power quality products and systems for the computer and depot repair and support of power quality products and systems for the computer and depot repair and support of power quality products and systems for the computer and
Design, Manufacture, Service and Distribution of Medical Imaging Software Systems with Off-the-Shelf Hardware. The design and manufacture of piezoelectric ceramic for the military, medical, automotive, geophysical and ultrasonic industries. Transducer and hydrophone array design and manufacture for military and commercial applications.
The management and protection of ERTOÆs corporate, client and customer information assets in the delivery of the Service for Operation and Maintenance of Tunnels and Traffic Control Centre, Egis Road and Tunnel Operation Ireland Ltd, Dublin ISO 27001:2013 Tunnel,Tunnel Control Building, East Wall Road, Dublin 3, D09 T3P6 and Jack Lynch Tunnel, Tunnel Management Building, Dunkettle, Glanmire, Co. Cork, T45 E898, in accordance with the Statement of Applicability version 1.2, dated 26th September 2016 The management and protection of ERTOÆs corporate, client and customer information assets in the delivery of the Service for Operation and Maintenance of Tunnels and Traffic Control Centre, Egis Road and Tunnel Operation Ireland Ltd, Dublin ISO 27001:2013 Tunnel,Tunnel Control Building, East Wall Road, Dublin 3, D09 T3P6 and Jack Lynch Tunnel, Tunnel Management Building Dunkettle, Glanmire, Co. Cork, T45 E898, in accordance with the Statement of Applicability version 1.0, dated 9th February 2016. THE SOURCING, COUNTERFEIT MITIGATION AND DISTRIBUTION OF ELECTRONIC AND ELECTRO-MECHANICAL AS 9120 - A PRODUCTS. BS OHSAS 18001:2007 Warehousing and Logistics for Computer Storage Products ISO 9001:2015 The Manufacture of Computer Storage Devices and Related Software Products ISO 14001:2015 The Manufacture of Computer Information Storage Devices and Related Software Products BS OHSAS 18001:2007 The Manufacture of Computer Information Storage Devices and Related Software Products ISO 9001:2015 Manufacture of Refractory Parts and Shapes Used in the Manufacture of Glass Products ISO 14001:2004 The manufacture of lead acid batteries and accessories.
Egis Road and Tunnel Operation Ireland
27.8018
Primary
Dublin 3
Ireland
Egis Road and Tunnel Operation Ireland
27.8018/A
Secondary
Dunkettle, Glanmire, Co. Cork
Ireland
Electronic Components, Inc.
AS19.4330
Single
Framingham
MA
USA
EMC Corporation EMC Information Systems International EMC Information Systems International EMC Information Systems International Emhart Glass Manufacturing Inc. EnerSys
18.8111 19.8115 14.8115 18.8115 19.324 14.018
Single Single Single Single Single Single
Franklin Ovens, Co. Cork Ovens, Co. Cork Ovens, Co. Cork Owensville Hays
MA
MO KS
USA Ireland Ireland Ireland USA USA
EnerSys
19.1333
Primary
Richmond
KY
USA
ISO 9001:2015
EnerSys EnerSys
19.1497 18.4123
Single Primary
Hays Gwent
KS
USA United Kingdom
ISO 9001:2015 OHSAS 18001:2007
EnerSys
19.1333/A
Secondary
Richmond
KY
USA
ISO 9001:2015
Manufacture of Lead Acid Batteries; Assembly of Battery Chargers; Distribution of Parts and Accessories.
EnerSys
19.1333/B
Secondary
Richmond
KY
EnerSys EnerSys EnerSys EnerSys
14.4123/A 19.4099/A 14.4123 19.4099
Secondary Secondary Primary Primary
Newport Newport Newport, Gwent Wales Gwent
EnerSys
TL19.1967X
Single
Reading
EnerSys
18.4123/A
Secondary
Newport, Gwent Wales
EnerSys Advanced Systems
AS19.4292
Single
Horsham
ENERSYS DE MEXICO II, S. DE R.L. DE C.V. ENERSYS DE MEXICO II, S. DE R.L. DE C.V. ENERSYS DE MEXICO S. DE R.L. DE C.V. ENERSYS DE MEXICO S. DE R.L. DE C.V. EnerSys Delaware Inc. EnerSys Energy Products EnerSys Energy Products, Inc.
19.3289/C 19.3289/B 19.3289/A 19.3289 19.3035 19.3592 14.0306
Secondary Secondary Secondary Primary Single Single Single
N.L. Mexico City Apodaca, N.L. N.L. Sumter Warrensburg Warrensburg
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
PA
Manufacture of Lead Acid Batteries; Assembly of Battery Chargers; Distribution of Parts and Accessories. Manufacture of Lead Acid Batteries The design and manufacture of sealed lead acid batteries.
USA
ISO 9001:2015
Manufacture of Lead Acid Batteries; Assembly of Battery Chargers; Distribution of Parts and Accessories.
United Kingdom United Kingdom United Kingdom United Kingdom
ISO 14001:2004 ISO 9001:2008 ISO 14001:2004 ISO 9001:2008
The design and manufacture of sealed lead acid batteries The design and manufacture of sealed lead acid batteries The design and manufacture of sealed lead acid batteries. The design and manufacture of sealed lead acid batteries.
USA
TL 9000 R6.0/R5.0
United Kingdom
OHSAS 18001:2007
PA
USA
AS 9100 - C
SC MO MO
Mexico Mexico Mexico Mexico USA USA USA
ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2015 ISO 14001:2004
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
TL9000-H Scope: The design and manufacture of Reserve Power Products DU, FTA, FTC, GT, GU, M Series, SBS, and VF batteries installed in telecom applications for specific telecom customers. in the following reporting categories: 5.3 Power Systems.ISO 9001:2008 Scope: The design, manufacture and service of batteries, chargers and accessories. The design and manufacture of sealed lead acid batteries. Design, development and manufacture of lithium ambient temperature, lithium thermal batteries, and lithium ion battery related products for the defense industry. The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays. Sales of industrial Batteries The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays. The Manufacture and Sales of Industrial Lead-Acid Batteries and Fabrication of Metal Trays. The Manufacture of Steel Trays and Products. Manufacture of Lead Acid Batteries The design and manufacture of lead acid batteries
01/18/18
Registration Number
Profile Type
CITY
EnerSys S.A.R.L.
19.4101
Single
EnerSys S.A.R.L.
14.4124
EnerSys S.A.R.L.
COMPANY
Country
Scheme
Arras
France
ISO 9001:2008
Single
Arras
France
ISO 14001:2004
18.8016
Single
Arras
France
EnerSys S.r.l.
19.4098
Single
Gambellara (VI)
Italy
EnerSys s.r.o.
19.4235
Secondary
Czech Republic
EnerSys s.r.o.
14.4235
Secondary
Czech Republic
EnerSys s.r.o.
19.4235/A
Primary
Czech Republic
EnerSys s.r.o.
14.4235/A
Primary
Czech Republic
EnerSys s.r.o.
19.4235/B
Secondary
Slovenska Republika
EnerSys Sp. z o.o.
18.4116
Single
43-300 Bielsko-Biala
Poland
EnerSys Sp. z o.o.
19.4116
Single
43-300 Bielsko-Biala
Poland
EnerSys Sp. z o.o.
14.4116
Single
43-300 Bielsko-Biala
Poland
ErgoMet Inc
19.4801
Single
Ward Hill
MA
USA
ISO 9001:2008
MD19.4911
Single
Mississauga
ON
Canada
ISO 13485:2016
Excelitas Canada Inc. Excelitas Canada Inc. Excelitas Canada Inc.
18.443 19.443 14.443
Single Single Single
Quebec Quebec Quebec
Canada Canada Canada
OHSAS 18001:2007 ISO 9001:2008 ISO 14001:2004
Excelitas Technologies (Shenzhen)
19.4449
Single
Shenzhen
China
ISO 9001:2008
Design of industrial flash lamps, manufacture of industrial flash lamps and solid state lighting products.
Excelitas Technologies (Shenzhen)
14.4449
Single
Shenzhen
China
ISO 14001:2004
Design of industrial flash lamps, manufacture of industrial flash lamps and solid state lighting products.
Excelitas Technologies (Shenzhen)
18.4449
Single
Shenzhen
China
OHSAS 18001:2007
Design of industrial flash lamps, manufacture of industrial flash lamps and solid state lighting products.
Excelitas Technologies Corp
18.3109
Single
Miamisburg
OH
USA
Excelitas Technologies Corp.
AS19.1679/A
Single
Covina
CA
USA
AS 9100 - D
Excelitas Technologies Corp.
19.3109
Single
Miamisburg
OH
USA
ISO 9001:2008
Design and manufacture of electro-optic components, energetic devices and electronic safe and arm devices.
Excelitas Technologies Corporation
14.0016
Single
Salem
MA
USA
ISO 14001:2004
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power conversion systems and X-ray sources.
Excelitas Technologies Corporation
MD19.4467
Single
Fremont
CA
USA
I.S.EN ISO13485:2012
Excelitas Technologies Corporation
19.1679
Single
Salem
MA
USA
ISO 9001:2008
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power conversion systems and X-ray sources.
Excelitas Technologies Corporation
18.1679
Single
Salem
MA
USA
BS OHSAS 18001:2007
The design and manufacture of electro-optical components, high energy switches, medical component, time frequency standards, high voltage power conversion systems and X-ray sources.
Excelitas Technologies Corporation
18.4641
Single
Covina
CA
USA
BS OHSAS 18001:2007 The design, manufacture and servicing of power supplies, power conditioning devices, and optoelectronic systems
Excelitas Technologies Corporation
14.4641
Single
Covina
CA
USA
Excelitas Technologies GmbH & Co.KG Excelitas Technologies GmbH & Co.KG
19.4461 18.4461
Single Single
Wiesbaden Wiesbaden
Excelitas Canada (Lumen Dynamics)
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
Germany Germany Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope Design, Development, Production, Sales and Servicing of Lead Acid Technology Industrial Batteries.Conception, dΘveloppement, production, vente et entretien de batteries au plomb - acide Design, Development, Production, Sales and Servicing of Lead Acid Technology Industrial BatteriesConception, Developpement, Production, Ventes et entretien des Batteries industrielles de technologie Plomb-Acide
BS OHSAS 18001:2007 Design, Development, Production, Sales and Servicing of Lead Acid Technology Industrial Batteries ISO 9001:2015
Sale and Installation of Traction, Stationary, Special Use Batteries and Accessories. Design, Development, Assembly, Sales and Service of ATEX Batteries and their Accessories. Assembly, Sales and Service of ISO 9001:2008 Industrial Batteries and their Accessories. Production of Trays for Industrial Batteries. Sales and Service of Reserve PowerSupplies, Sales and Service of Motive Power Batteries. Design, Development, Assembly, Sales and Service of ATEX Batteries and their Accessories. Assembly, Sales and Service of ISO 14001:2015 Industrial Batteries and their Accessories. Production of Trays for Industrial Batteries. Sales and Service of Reserve PowerSupplies, Sales and Service of Motive Power Batteries. Design, Development, Assembly, Sales and Service of ATEX Batteries and their Accessories. Assembly, Sales and Service of ISO 9001:2008 Industrial Batteries and their Accessories. Production of Trays for Industrial Batteries. Sales and Service of Reserve PowerSupplies, Sales and Service of Motive Power Batteries.Osvedcenφ o registraci Design, Development, Assembly, Sales and Service of ATEX Batteries and their Accessories. Assembly, Sales and Service of ISO 14001:2015 Industrial Batteries and their Accessories. Production of Trays for Industrial Batteries. Sales and Service of Reserve PowerSupplies, Sales and Service of Motive Power Batteries. Design, Development, Assembly, Sales and Service of ATEX Batteries and their Accessories. Assembly, Sales and Service of ISO 9001:2008 Industrial Batteries and their Accessories. Production of Trays for Industrial Batteries. Sales and Service of Reserve PowerSupplies, Sales and Service of Motive Power Batteries. Design & Development Assistance; Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components and Final BS OHSAS 18001:2007 Assembly of Chargers. Design and Development Assistance; Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components and ISO 9001:2008 Final Assembly of Chargers Design and Development Assistance; Production and Sales of Lead-Acid Cells, Lead-Acid Batteries and Components and ISO 14001:2004 Final Assesmbly of Chargers Manufacturing of Precision Sheet Metal parts and assemblies for diverse industries, including medical. The Design and Manufacture of Precision Light Sources and Delivery Systems for use in Photochemical and Medical Illumination System Components Design, Manufacturing and Test of Optoelectronic Devices. Design, Manufacturing and Test of Optoelectronic Devices. The Design, Manufacturing and Test of Optoelectronic Devices.
BS OHSAS 18001:2007 Design and manufacture of electro-optic components, energetic devices and electronic safe and arm devices.
ISO 14001:2004
The Design, Manufacture and Servicing of Power Supplies, Power Conditioning Devices and Optoelectronic Systems.
ISO 13485 Scope: Design, development, manufacture and distribution of electrical lamps, lamp modules, optical equipment and power supplies including system integration and testing for the medical device industry.ISO 9001 Scope: Design, development, manufacture and distribution of specialty lamps, lighting equipment, optical equipment and power supplies for the medical, industrial, communication, aerospace, scientific, entertainment and military markets.
The design, manufacture and servicing of power supplies, power conditioning devices and optoelectronic systems.
ISO 9001:2015 Design and Distribution of Optoelectronic Products BS OHSAS 18001:2007 Design and Distribution of Optoelectronic Products.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Excelitas Technologies Inc.
18.4467
Secondary
Fremont
CA
USA
BS OHSAS 18001:2007
Design, Development, Manufacture and Distribution of Specialty Lamps, Lighting, Optical Equipment and Power Supplies for the Medical, Industrial, Communication, Aerospace, Scientific, Entertainment and Military Markets
Excelitas Technologies Inc.
MD19.4632
Single
Wheeling
IL
USA
ISO 13485:2003
MD Scope: The Design, Manufacture and Contract Development of LED Electrical Lamps and Lamp Modules for the Medical Device Industry.ISO9K Scope: Design and Manufacture of LED Based Lighting Solutions.
Excelitas Technologies Inc.
14.4467
Single
Fremont
CA
USA
ISO 14001:2004
Design, Development, Manufacture and Distribution of Specialty Lamps, Lighting, Optical Equipment and Power Supplies for the Medical, Industrial, Communication, Aerospace, Scientific, Entertainment and Military Markets.
14.4447 18.4447 19.4447 19.4455/B
Single Single Single Secondary
Laguna Laguna Laguna
Philippines Philippines Philippines Singapore
ISO 14001:2004 OHSAS 18001:2007 ISO 9001:2008 ISO 9001:2008
Falcona Management & Technology
19.8099
Single
San Antonio
TX
USA
ISO 9001:2015
The provision of management and technical services in programmatic support, systems engineering, and technology management solutions to the Department of Defense, government agencies and commercial customers.
FAR Chemical, Inc.
19.4009
Single
Palm Bay
FL
USA
ISO 9001:2008
The Design, Development and Manufacture of Chemicals, Polymers, and Pharmaceutical Intermediates.
FastForm Research Ltd
MD19.3771
Single
Co Waterford
Ireland
I.S.EN ISO13485:2012
Fiberoptic Components, LLC
MD19.4287
Single
Sterling
USA
I.S.EN ISO13485:2012
Filtertek
MD19.2602
Single
Co. Limerick
Ireland
I.S.EN ISO13485:2012
Fire Safe Products Fire Safe Products Fire Safe Products First State Mfg.
19.8117 19.8117/A 19.8117/B AS19.4697
Primary Secondary Secondary Single
Pevely Fredericktown Walford Milford
USA USA USA USA
ISO 9001:2015 ISO 9001:2008 ISO 9001:2008 AS 9100 - D
The design and development, manufacture, and distribution of medical devices for orthopaedic and soft-tissue splinting and support. ISO 13485:2003 Scope: The Design and Manufacture of Fiber Optic Cable, Components and Sub Assemblies for the Medical Device Industry.ISO 9001:2015 Scope: The Design and Manufacture of Fiber Optic Cable, Components and Sub Assemblies for the Commercial and Medical Device Industry. The Design, Manufacture, Packaging and Distribution of Sterile and Non-Sterile Plastic Moulded Products, Filters and Valves for the Medical Device Industry. Design, Manufacture Warehouse, Distribution, and Servicing of Filtration Products Design, Manufacture Warehouse, Distribution, and Servicing of Filtration Products Design, Manufacture Warehouse, Distribution, and Servicing of Filtration Products Manufacture of Custom Sewn & Upholstered products for the Aerospace Industry
Fleming Medical
MD19.8083
Single
Limerick
Ireland
I.S.EN ISO13485:2012
The Manufacture and Distribution of Medical Diagnostic Equipment, including Service Support, and Healthcare Consumables.
FlexDex Inc.
MD19.8101
Single
Brighton
USA
I.S.EN ISO13485:2012
Fluidmaster Water Technology
19.3131/B
Single
Guadalupe, N.L.
Mexico
ISO 9001:2008
The Design, Manufacture, and Distribution of Manually Operated Articulating Needle Drivers for use during Laparoscopic Surgery The manufacture and assembler of toilet trim and proprietary plumbing products.
19.3131
Single
San Juan Capistrano
CA
USA
ISO 9001:2015
The design, pilot production, sales and supply chain management of toilet trim and proprietary plumbing products. The Manufacture of Corrugated and Foam Packaging.
COMPANY
Excelitas Technologies Philippines, Inc. Excelitas Technologies Philippines, Inc. Excelitas Technologies Philippines, Inc. Excelitas Technologies Singapore Pte Ltd
Fluidmaster, Inc. Foam Pack/Future Pack
MA
MO MO IA DE
MI
Scope
Manufacture and Test of Optoelectronic Components and Assemblies. Manufacture and Test of Optoelectronic Components and Assemblies. Manufacture and Test of Optoelectronic Components and Assemblies. Design and Manufacture of Optoelectronics Products
19.415
Single
San Juan
PR
Puerto Rico
ISO 9001:2008
Focal Therapeutics
MD19.4786/B
Primary
Sunnyvale
CA
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of Bioabsorbable Radiopaque Tissue Markers, and Associated Accessories.
Focal Therapeutics
MD19.4786/A
Secondary
Aliso Viejo
CA
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of Bioabsorbable Radiopaque Tissue Markers, and Associated Accessories.
MD19.4450
Single
Chelmsford
MA
USA
I.S.EN ISO13485:2012
19.4506
Single
Twinsburg
OH
USA
ISO 9001:2015
FTT Medical Inc
MD19.8051
Single
Rochester
NY
USA
ISO 13485/CMDCAS
G&F Industries, Inc. G&F Medical, Inc.
19.4944 MD19.4887
Single Single
Sturbridge Danvers
MA MA
USA USA
ISO 9001:2008 I.S.EN ISO13485:2012
19.4215
Primary
Chicago
IL
USA
ISO 9001:2015
AS19.3128/A
Single
Salem
OR
USA
AS 9100 - C
Garmin International
AS19.3128
Primary
Olathe
KS
USA
AS 9100 - C
Garmin International
14.3128
Primary
Olathe
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information Devices with Applications for Aerospace, Marine, Outdoor Recreation, Automotive, Wireless and OEM Markets.
Garmin International
14.3128/A
Secondary
New Century
KS
USA
ISO 14001:2004
Design, Manufacture, Distribution and Support of Navigation, Communication, and Information Devices with Applications for Aerospace, Marine, Outdoor Recreation, Automotive, Wireless and OEM Markets.
Garmin International
19.3128
Single
Olathe
KS
USA
ISO 9001:2008
Design, manufacture, distribution, and support of navigation, communication, and information devices with applications for aerospace, marine, outdoor recreation, automotive, wireless and OEM markets.
Foresight Imaging, LLC Freedom USA, Inc.
G.E. Mathis Company Garmin AT
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
ISO 13485: The design, manufacture, sales and service of video imaging boards, systems and software for medical markets.ISO 9001: The design, manufacture, sales and service of video imaging boards, systems and software for medical and industrial markets. Internet processing of custom hardware and software solutions, assembly, repair and consulting services for one stop shop end users. The Design, Manufacture, Distribution and Service of Active Illumination Devices and Non-Active Surgical Instruments The Manufacture of Injection Molded Parts. The Manufacture of Injection Molded Components for the Medical Device Industry. Manufacture of general steel fabrications and assemblies for, but not limited to, industries such as; agricultural equipment, chemical container, construction equipment, energy and mining. Design, Manufacture, Certification, Distribution, and Support of Navigation, Communication, and Flight Control Equipment for Aerospace Applications. AS9100 Scope: Design, Manufacture, Certification, Distribution, and Support of Navigation, Communication, and Flight Control Equipment for Aerospace Applications.ISO 9001:2008 Scope: Design, manufacture, distribution, and support of navigation, communication and information devices with applications for aerospace, marine, outdoor recreation, automotive, wireless and OEM markets
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
AS19.3128/B
Secondary
New Century
KS
USA
AS 9100 - C
GatesAir, Inc.
19.1841/A
Single
Quincy
IL
USA
ISO 9001:2015
Manufacturing, Order Management, Program Management, Supply Chain Management, Sustaining Engineering and Repair of Radio, Television, and Networking Products for use in Broadcast Communications and Related Media Industries.
GatesAir, Inc.
18.4117X
Single
Quincy
IL
USA
BS OHSAS 18001:2007
Manufacturing, Order Management, Program Management, Supply Chain Management, Sustaining Engineering and Repair of Radio, Television, and Networking Products for use in Broadcast Communications and Related Media Industries.
GatesAir, Inc.
14.4127X
Single
Quincy
IL
USA
ISO 14001:2015
Manufacturing, Order Management, Program Management, Supply Chain Management, Sustaining Engineering and Repair of Radio, Television, and Networking Products for use in Broadcast Communications and Related Media Industries.
GAZ GmbH
COMPANY Garmin International
Scope Flight Operations center performing Design and Certification activities in support of Navigation, Communication, and Flight Control Equipment for Aerospace Applications
19.4102/A
Secondary
D-08056 Zwickau
Germany
ISO 9001:2015
Production, Sales and Service of Industrial Batteries and Aircraft NiCd Batteries and Accessories
Gemini Technical Services, Inc. GemTech LLC
19.4255 19.8053
Single Single
Bow Olathe
NH KS
USA USA
ISO 9001:2008 ISO 9001:2015
Geneva Laboratories
19.4248
Primary
Elkhorn
WI
USA
ISO 9001:2008
Geneva Laboratories
19.4248/A
Secondary
Elkhorn
WI
USA
ISO 9001:2008
GENEWIZ UK Ltd.
19.8032
Single
Repair of Printed Circuit Boards and Associated Assemblies Contract manufacture of injection molded components for various industries. Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing applicable International and U.S. standards for a variety of medical device, supplies, laboratory and diagnostic products. Chemical and electricaltesting of electronic components and assemblies used in instruments. Biocompatibility, microbiological, chemical, electronic, safety, and toxicological testing utilizing applicable International and U.S. standards for a variety of medical device, supplies, laboratory and diagnostic products. Chemical and electricaltesting of electronic components and assemblies used in instruments. The provision of genomic services.
Genia Medical, Inc.
MD19.4990
Single
Orlando
FL
Germiphene Corporation
MD19.4994
Single
Brantford ON
Gibson Bioscience
MD19.8005
Single
Lexington
Global Instrumentation LLC
MD19.4221
Single
Globaltek Components LLC
19.4589
Single
GRAFTYS
MD19.4529
Primary
GRAFTYS
MD19.4529/A
GRAFTYS
United Kingdom
ISO 9001:2008
USA
I.S.EN ISO13485:2012
Canada
I.S.EN ISO13485:2012
KY
USA
I.S.EN ISO13485:2012
Manlius
NY
USA
ISO 13485/CMDCAS
Dover
NH
USA
ISO 9001:2008
Cedex 3
France
ISO 13485/CMDCAS
Secondary
Cedex 3
France
ISO 13485/CMDCAS
MD19.4529/B
Secondary
Cedex 3
France
ISO 13485/CMDCAS
Greatbatch Medical
MD19.4896/A
Secondary
Fort Wayne
IN
USA
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical
MD19.4896/B
Secondary
Indianapolis
IN
USA
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical
MD19.4896/C
Secondary
Chaumont
France
ISO 13485/CMDCAS
Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. (Corporate Headquarters, and the Sales, Marketing, and Customer Service area for commercial business)
Greatbatch Medical
MD19.4895
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
Greatbatch Medical
MD19.4896
Primary
Clarence
NY
USA
ISO 13485/CMDCAS
Greatbatch Medical
19.4007
Single
Minneapolis
MN
USA
ISO 9001:2008
Greatbatch Medical
MD19.8039
Primary
Clarence
NY
USA
I.S.EN ISO13485:2012
Greatbatch Medical
MD19.8039/A
Secondary
Alden
NY
USA
I.S.EN ISO13485:2012
Greatbatch Medical - Beaverton
MD19.4897
Single
Beaverton
OR
USA
ISO 13485:2003
Greatbatch Medical S. de R.L. de C.V
MD19.4937
Single
Tijuana, BC CP
Mexico
I.S.EN ISO13485:2012
Greatbatch Medical, S. de R.L. de C.V.
MD19.4211
Single
Tijuana, B.C.
Mexico
ISO13485:2003
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The Design and Development and Manufacture of Non-Sterile, Mechanical and Electromechanical Medical Devices. MD & ISO 9K: Manufacture and Distribution of Disinfectants, Cleaning Solutions, and Dental Products for the Medical Device Industry. Manufacture and Distribution of Examination Gloves.CMDCAS: Manufacture and Distribution of Non-sterile Medical Examination Gloves. The Manufacture and Distribution of In-Vitro Medical Devices, including Controls, Reagents, Stains, Lyophilized Bacterial and Fungal Cultures, Fungal Serology and Media. The design, development, manufacture, distribution, installation and servicing of ECG acquisition and Analysis Systems for Medical Applications. Electronic Distributor, Third Party Logistics and Asset Recovery Provider The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems. The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems. The Design, Manufacture and Distribution of Sterile Calcium Phosphate Resorbable Bone Void Fillers and related Delivery Systems.
Design and Development, Manufacture, Contract Manufacture, and Distribution of Active Implantable Medical Devices, Implantable Leads for AIMDs and Related Accessories, Percutaneous Introducer Systems, Intravascular Catheters, Delivery Sheaths,Safety Needles and Components. Design, development, manufacturing, and distribution of orthopaedics and trauma implants, instruments and sterilization cases, trays and lids. The Manufacture of Deep Drawn Device Enclosures, Cases, and Complex Stampings for Implantable Medical Devices and other Commercial Applications. The Design, Manufacture and Test of Capacitors and Lithium Batteries, Lithium Ion Rechargeable Batteries, Feedthroughs, Filter Feedthroughs, Shield Assemblies, Coated Components, and Ceramics for Use in Implantable and Non-Implantable Medical Devices The Design, Manufacture and Test of Capacitors and Lithium Batteries for use in Implantable Medical Devices, and Lithium Ion Rechargeable Batteries for Medical Applications Design and Distribution of Portable Power Solutions for Medical Devices. Manufacture and Service of Portable Battery Power Solutions and Accessories for Medical Device Applications The Manufacture, Assembly and Testing of Components and Sub-Assemblies for Implantable Medical Devices and other Medical Applications including Feedthroughs and Filtered Feedthroughs and the Manufacture of non sterile, Acetabular Reamer orthopedicinstruments and the Manufacture of Sterile and Non-Sterile Introducer, Catheter and Components.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Greatbatch. Inc.
19.4696
Primary
Raynham
MA
USA
ISO 9001:2008
The Design and Manufacture of Specialty Lithium Primary and Rechargeable Batteries and Battery Packs.
Greatbatch. Inc.
19.4696/A
Secondary
Taunton
MA
USA
ISO 9001:2008
The design and manufacture and specialty lithium primary and rechargeable batteries and battery packs.
19.4569
Single
Chesapeake
VA
USA
ISO 9001:2008
Provisioning of Telecommunications, Information Technology, Program Management, Logistics, Administration, and Engineering support services for government and commercial contracts.
Haemoband Surgical Ltd.
MD19.8010
Single
Belfast
United Kingdom
ISO 13485/CMDCAS
Harbor MedTech
MD19.4836
Single
Irvine
USA
I.S.EN ISO13485:2012
MD19.4090/A
Secondary
Castlerea Co. Roscommon
Ireland
I.S.EN ISO13485:2012
Harmac Medical Products, Inc.
MD19.4090
Primary
Buffalo
USA
I.S.EN ISO13485:2012
Harmac Medical Products, Inc.
MD19.4090/B
Secondary
Nueva Tijuana
Mexico
I.S.EN ISO13485:2012
Harmac Medical Products, Inc.
14.0634/01
Secondary
Buffalo
NY
USA
ISO 14001:2015
Harmonic Drive LLC
AS19.1630/A
Secondary
Peabody
MA
USA
AS 9100 - C
The design, manufacture and sale of precision gear reducers, servo-actuators and electro-mechanical positioning systems.
Harmonic Drive LLC
AS19.1630
Primary
Peabody
MA
USA
AS 9100 - C
The design, manufacture and sale of precision gear reducers, servo-actuators and electro-mechanical positioning systems.
19.4102
Primary
D-58089 Hagen
Germany
ISO 9001:2015
HAWKER GmbH HAWKER GmbH Hawker Powersource, Inc. Hawker Powersource, Inc. Hawker Powersource, Inc. Hexavision SARL
14.034 18.4102 19.3593/A 19.3593/B 19.3593 MD19.4494
Single Single Secondary Secondary Primary Single
D-58089 Hagen D-58089 Hagen Ooltewah Ooltewah Ooltewah Paris
Germany Germany USA USA USA France
ISO 14001:2015 BS OHSAS 18001:2007 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 I.S.EN ISO13485:2012
Hitachi Cable America, Inc.
19.4489
Single
Manchester
USA
ISO 9001:2015
COMPANY
GStek, Inc.
Harmac Medical Products
HAWKER GmbH
CA
NY
TN TN TN NH
Hollister Incorporated
MD19.4106
Primary
Libertyville
IL
USA
I.S.EN ISO13485:2012
Hollister Incorporated Hollister Incorporated
MD19.4106/E MD19.4106/C
Secondary Secondary
Kirksville Stuarts Draft
MO VA
USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
MD19.4554
Single
Haryana
India
I.S.EN ISO13485:2012
Hollister Services BV
MD19.4106/A
Secondary
The Netherlands
ISO 13485/CMDCAS
Hollister ULC
MD19.4106/D
Secondary
Rehins, Ballina, Co. Mayo
Ireland
I.S.EN ISO13485:2012
Hollow Fiber Systems, LLC
MD19.8004
Single
Rochester
USA
ISO 13485:2003
Homecare Medical Supplies
MD19.8100
Primary
Ballyhaunis, Co Mayo
Ireland
I.S.EN ISO13485:2012
Homecare Medical Supplies
MD19.8100/A
Secondary
Co Mayo
Ireland
I.S.EN ISO13485:2012
Hollister Medical India Private Limited
Scope
The Design, Manufacture and Distribution of Devices for Banding of Tissues. Design, Manufacture and Distribution of stabilized (equine) collagen matrix products for wound care. The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components and the Contract Manufacturing of Non-Active Implantable Medical Devices Including Devices Containing Tissue of Animal Origin. The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components and the Contract Manufacturing of Non-Active Implantable Medical Devices Including Devices Containing Tissue of Animal Origin. The Design, Development, Manufacture and Contract Manufacturing of Disposable Medical Devices and Plastic Components and the Contract Manufacturing of Non-Active Implantable Medical Devices Including Devices Containing Tissue of Animal Origin. The design, development, manufacture and contract manufacture of disposable medical devices and plastic components and non-active implantable medical devices.
Production, Sales and Service of Industrial Batteries and Aircraft NiCd Batteries and Accessories Production, Sales and Service of Industrial Batteries and Accessories Production, Sales and Service of Industrial Batteries and Accessories Design and Manufacture of Industrial Batteries; Assembly of Chargers Design and Manufacture of Industrial Batteries; Assembly of Chargers Design and Manufacture of Industrial Batteries; Assembly of Chargers The design and development, manufacture and distribution of sterile intraocular lenses. Drawing and insulation of nonferrous wire, design and manufacture of copper and fiber optic cable for the telecommunications, data and electronic markets. MD: The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Non-sterile Disposable Medical Products Intended for Ostomy Care, Continence Care, Wound Care, and Critical Care, and the Contract Manufacturing of Sterile andNon-Sterile Disposable Medical Products Intended for Ostomy Care, Obstetrics, Gynecology, Newborn and Pediatric Care.CM: The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Non-Sterile Disposable Medical Products Intended for Ostomy Care, Continence Care, Wound Care, and Critical Care.
The Manufacture of Sterile & Non-Sterile Medical Devices for the treatment of Incontinence, including Urinary Intermittent Catheters, Coude Taper Tip Urinary Intermittent Catheters, Urinary Catheterization Systems, Urinary Catheterization Kits andCatheter Insertion Kits. The Design, Manufacture and Distribution of External and Invasive Use, Sterile and Non-sterile, Disposable Medical Devices Intended for Ostomy, Incontinence, Wound Care Products and the Contract Manufacture of Sterile and Non-Sterile Obstetrics,Gynecology, Newborn, and Pediatric Products.
Hubbell Power Systems, Inc./
19.1864
Single
Boonton
NJ
USA
ISO 9001:2008
Hutchinson Technology, Inc., Hutchinson Technology, Inc.,
19.1951 19.1951/A
Primary Secondary
Hutchinson Eau Claire
MN WI
USA USA
ISO 9001:2015 ISO 9001:2015
The provision of contract manufacturing administration, supply chain management and manufacturing engineering services for the medical device industry The installation and distribution of medical equipment and consumables including the decontamination, servicing and field servicing of medical equipment. The installation and distribution of medical equipment and consumables including the decontamination, servicing and field servicing of medical equipment. Provide CNC Precision Machinging Services and Mechanical Assemblies, Precision Machining of Metal and Plastic Parts, CNC Milling and Turning Machining. The Manufacture and Distribution of Sterile and Non-Sterile Lubricating and Ultrasound Jelly The Manufacture and Distribution of Sterile and Non-Sterile Lubricating and Ultrasound Jelly The Manufacture and Distribution of Sterile and Non-Sterile Lubricating and Ultrasound Jelly The design and manufacture of electronic equipment and components for communication and relaying products in the electric utilities and transportation markets. The Design, Development and Manufacture of Components. The Design, Development and Manufacture of Components.
14.442
Primary
Pocasset
MA
USA
ISO 14001:2015
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems
MN
Houck Machine Company
19.4709
Single
Plymouth
MN
USA
ISO 9001:2008
HR Pharmaceuticals, Inc. HR Pharmaceuticals, Inc. HR Pharmaceuticals, Inc.
MD19.8093 MD19.8093/A MD19.8093/B
Primary Secondary Secondary
York York York
PA PA PA
USA USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
Hydroid, Inc ** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Hydroid, Inc
18.442
Primary
Pocasset
MA
USA
OHSAS 18001:2007
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
Hydroid, Inc
19.4420/A
Secondary
Portchester
United Kingdom
ISO 9001:2015
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems
Hydroid, Inc
18.4420/A
Secondary
Portchester
United Kingdom
OHSAS 18001:2007
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
Hydroid, Inc
19.4420/B
Secondary
Pocasset
MA
USA
ISO 9001:2015
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems
Hydroid, Inc
18.4420/B
Secondary
Pocasset
MA
USA
OHSAS 18001:2007
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
Hydroid, Inc Hydroid, Inc
14.4420/B 14.4420/A
Secondary Secondary
Pocasset Portchester
MA
USA United Kingdom
ISO 14001:2015 ISO 14001:2015
The design, software development, manufacture, sales and service of Marine Robotic Systems The design, software development, manufacture, sales and service of Marine Robotic Systems
Hydroid, Inc
19.442
Primary
Pocasset
MA
USA
ISO 9001:2015
The Design, Software Development, Manufacture, Sales and Service of Marine Robotic Systems.
MD19.4678
Single
Durham
NC
USA
I.S.EN ISO13485:2012
19.4547
Single
Reston
VA
USA
ISO 9001:2008
MD19.3293
Single
St. Paul
MN
USA
I.S.EN ISO13485:2012
Contract design and manufacturing services for sterile and non-sterile medical devices and medical device assemblies.
I.S.EN ISO13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories, enteral feeding valves, vial access devices,infusion sets, monitoring devices and sterile leur access valve disinfectant cap. The manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
COMPANY
HyperBranch Medical Technology, Inc Hyperion Inc. I-TEK Medical Technologies
ICU Medical de Mexico,S. de R.L. de C.V.
MD19.4496/C
Secondary
Ensenada
Mexico
Scope
The design, development and manufacture of crosslinked hydrogel polymer sealants and related delivery systems. Management and Design of Information Technology Projects.
ICU Medical, Inc.
MD19.4496/B
Secondary
Salt Lake City
UT
USA
I.S.EN ISO13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories, enteral feeding valves, vial access devices,infusion sets, monitoring devices and sterile leur access valve disinfectant cap. The manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
ICU Medical, Inc.
MD19.4496
Primary
San Clemente
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories, enteral feeding valves, vial access devices,infusion sets, monitoring devices and sterile leur access valve disinfectant cap. The manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006.
USA
I.S.EN ISO13485:2012
The design, manufacture, sterilization and distribution of intravenous catheters, IV administration sets, custom IV kits, IV connectors, molded sub-assemblies and accessories, enteral feeding valves, vial access devices,infusion sets, monitoring devices and sterile leur access valve disinfectant cap. The manufacture, repair and servicing of optical modules for oxygen measurement. Irradiation sterilization of medical devices in accordance with ISO 11137-1:2006. The Design and Development, Manufacture and Distribution of Medical Imaging Software
ICU Medical, Inc.
MD19.4496/F
Secondary
San Clemente
CA
Imagilys SPRL
MD19.8095
Single
Immunetics, Inc
MD19.4328
Belguim
I.S.EN ISO13485:2012
Single
Boston
MA
USA
ISO 13485/CMDCAS
IMPAKT Holdings, LLC/
19.4959
Primary
Santa Clara
CA
USA
ISO 9001:2008
Build to print contract manufacturer incorporating machining, sheet metal fabrication, welding and assembly operations.
IMPAKT Holdings, LLC/
19.4959/A
Secondary
Santa Clara
CA
USA
ISO 9001:2008
Build to print contract manufacturer incorporating machining, sheet metal fabrication, welding and assembly operations.
19.4338
Single
Reston
VA
USA
ISO 9001:2008
Inmo-Tech Ltd.
MD19.5521
Single
Co. Sligo
Ireland
I.S.EN ISO13485:2012
InnovaQuartz LLC
MD19.8035
Single
Phoenix
AZ
USA
ISO 13485/CMDCAS
InPress Technologies Inc.
MD19.4858
Single
San Luis Obispo
CA
USA
I.S.EN ISO13485:2012
19.4946
Single
Hudson
NH
USA
ISO 9001:2008
INTA Technologies
AS19.4204
Single
Santa Clara
CA
USA
AS 9100 - C
Delivery, management, sale and integration of IP (internet protocol) network services and equipment for satellite and terrestrial infrastructures. MD Scope: Moulding of medical device components, and assembly of components and subassemblies for the medical device industry.ISO9K Scope: Contract Injection Moulding and Manufacturing. The Design and Development , Manufacture and Distribution of Fiber-Optic Delivery Fibers for Laser-Based Surgical Applications. The Design, Manufacture and Distribution of non-active WomenÆs Health Care Products for the Treatment of Postpartum Hemorrhage Contract manufacturer of discrete wire & lug assemblies, wire harnesses, cable assemblies, over molded cables and molded cable products Chemical Processing, Electroplated and Metallized Ceramic and Metal Parts and Assemblies.
InTECHrity Inc
MD19.4723
Single
Irvine
CA
USA
I.S.EN ISO13485:2012
Contract manufacturing of non-sterile therapeutic medical devices used in the treatment of speech and swallowing disorders.
Intel Corporation Intel Corporation Intel Corporation Intel Corporation Intel Corporation
18.0246/B 18.0246/H 18.0246/I 18.0246 14.0246/B
Secondary Secondary Secondary Primary Secondary
Chandler Rio Rancho Hillsboro Santa Clara Chandler
AZ NM OR CA AZ
USA USA USA USA USA
OHSAS 18001:2007 OHSAS 18001:2007 OHSAS 18001:2007 OHSAS 18001:2007 ISO 14001:2015
Inmarsat Government, Inc.
Inside Track Cabling
The Design, Development, Manufacture and Distribution of ELISA Diagnostic Kits and Microorganism Detection Systems.
The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors.
Intel Corporation
19.1804
Primary
San Jose
CA
USA
ISO 9001:2015
Design, Development and Provision of Total Solutions, Including Semiconductor Components, IP, and Development Tools.
Intel Corporation
19.4325/H
Secondary
Santa Clara
CA
USA
ISO 9001:2015
Wafer Fabrication, Associated Equipment and Processes
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
01/18/18
Intel Corporation Intel Corporation Intel Corporation Intel Corporation Intel Corporation Intel Corporation Intel Corporation
14.0246/O 19.4325/A 14.0246/I 19.4326 14.0246/P 14.0246/H 14.0246/J
Profile Type Secondary Secondary Secondary Primary Secondary Secondary Secondary
Intel Corporation
19.1804/A
Secondary
Bayan Lepas/Penang
Intel Corporation Intel Corporation Intel Corporation Intel Corporation Intel Corporation - ATTD Intel Corporation - ATTD Intel Corporation - D1C Intel Corporation - Fab 11X Intel Corporation - Fab 28 Intel Corporation - Fab 32 Intel Corporation - Fab 68 Intel Corporation OTD Intel Corporation-Fab/Sort Manufacturing Intel GRL EMEA Intel Ireland Ltd. Intel Ireland Ltd. Intel Ireland Ltd. Intel Ireland Ltd. - Fab 24 Intel Products (Chengdu) Ltd Intel Products (Chengdu) Ltd Intel Products (Chengdu) Ltd Intel Products (Chengdu) Ltd. - CD DSDP Intel Products (Chengdu) Ltd. - CDAT Intel Products (M) Sdn. Bhd.
14.0246 18.0246/J 18.0246/O 18.0246/P 19.4326/A2 19.4326/A 19.4325/L 19.4325/C 19.4325/N 19.4325/M 19.8124 19.4326/A3 19.4325 19.0963US 14.0246/G 18.0246/G 93.0042 19.4325/G 14.0246/Q 18.0246/Q 93.0041 19.4326/C 19.4326/D 14.0246/N
Primary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Single Secondary Primary Single Secondary Secondary Single Secondary Secondary Secondary Single Secondary Secondary Secondary
Santa Clara Aloha Qiryat Gat Chandler Hillsboro Chandler Hillsboro Rio Rancho Qiryat Gat Chandler Dalian, LN Aloha Chandler County Kildare Leixlip, County Kildare Leixlip, County Kildare Co. Kildare Leixlip, County Kildare Chengdu, Sichuan Chengdu, Sichuan Chengdu Chengdu City, Sichuan Province Chengdu City, Sichuan Province Kulim
Intel Products (M) Sdn. Bhd.
93.0051US
Single
Kamlung
Intel Products (M) Sdn. Bhd. Intel Products (M) Sdn. Bhd. - SIMS Intel Products Vietnam Intel Products Vietnam Co., Ltd Intel Products Vietnam, Ltd. Intel Products Vietnam, Ltd. Intel Semiconductor (Dalian) Ltd. Intel Semiconductor (Dalian) Ltd. Intel Technology Sdn. Bhd - PGAT Intel Technology Sdn. Bhd. Intel Technology Sdn. Bhd. Intel Technology Sdn. Bhd. - KuAT International Titanium Corporation Intersect ENT
18.0246/N 19.4326/F 93.0048 19.4326/O 14.0246/R 18.0246/R 14.0246/S 18.0246/S 19.4326/K 14.0246/D 18.0246/D 19.4326/N 19.4234 MD19.4737
Secondary Secondary Single Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Secondary Single Single
Kulim Kedah Darul Aman Ho Chi Minh City Ho Chi Minh City Ho Chi Minh City Ho Chi Minh City Dalian, LN Dalian, LN Penang Penang Penang Kulim, Kedah New Brighton Menlo Park
Kedah
PA CA
Malaysia Malaysia Vietnam Vietnam Vietnam Vietnam China China Malaysia Malaysia Malaysia Malaysia USA USA
Intuitive Research & Technology Corp.
AS19.4317
Single
Huntsville
AL
USA
AS 9100 - C
iRhythm Technologies, Inc.
MD19.4861/A
Secondary
Cypress
CA
USA
I.S.EN ISO13485:2012
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The Provision of ECG data recovery, analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
MD19.4861
Primary
San Francisco
CA
USA
I.S.EN ISO13485:2012
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The Provision of ECG data recovery, analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
MD19.4861/C
Secondary
Guildford Surrey
United Kingdom
I.S.EN ISO13485:2012
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The Provision of ECG data recovery, analysis, and report generation services for physicians.
iRhythm Technologies, Inc.
MD19.4861/B
Secondary
Lincolnshire
IL
USA
I.S.EN ISO13485:2012
The design, manufacture and distribution of wearable, single-patient-use Electrocardiograph (ECG) monitors, and associated analysis software. The Provision of ECG data recovery, analysis, and report generation services for physicians.
MD19.2686
Primary
Santa Ana
CA
USA
ISO 13485/CMDCAS
COMPANY
Irvine Scientific
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Registration Number
CITY
STATE
Country
Scheme
Qiryat Gat Aloha Hillsboro Chandler Chandler Rio Rancho Aloha
OR OR AZ AZ NM OR
Israel USA USA USA USA USA USA
ISO 14001:2015 ISO 9001:2015 ISO 14001:2015 ISO 9001:2015 ISO 14001:2015 ISO 14001:2015 ISO 14001:2015
The Manufacturing of Semi-conductors. Wafer Fabrication, Associated Equipment and Processes. The Manufacturing of Semi-conductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors.
Malaysia
ISO 9001:2015
Design, Development and Provision of Total Solutions, Including Semiconductor Components, IP, and Development Tools.
USA USA Israel USA USA USA USA USA Israel USA China USA USA Ireland Ireland Ireland Ireland Ireland China China China China China Malaysia
ISO 14001:2015 OHSAS 18001:2007 OHSAS 18001:2007 OHSAS 18001:2007 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007 ISO 50001:2011 ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007 ISO 50001 ISO 9001:2015 ISO 9001:2015 ISO 14001:2015
Malaysia
ISO 50001 OHSAS 18001:2007 ISO 9001:2015 ISO 50001 ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007 ISO 14001:2015 OHSAS 18001:2007 ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007 ISO 9001:2015 ISO 9001:2008 I.S.EN ISO13485:2012
CA OR AZ OR AZ OR NM AZ OR AZ
Kedah
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes Assembly and Test of Semiconductor Components, Associated Equipment and Processes Wafer Fabrication, Associated Equipment and Processes Wafer Fabrication, Associated Equipment and Processes Wafer Fabrication, Associated Equipment and Processes Wafer Fabrication, Associated Equipment and Processes The Manufacture of Non-Volatile Memory (NVM) Wafers. Oregon Technology Development Test Labs Wafer Fabrication, Associated Equipment and Processes The provision of reverse logistics services for Intel products in the EMEA region. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The manufacture of integrated circuits and electronic building blocks for the computer industry. Wafer Fabrication, Associated Equipment and Processes The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. Manufacture assembly and test of semiconductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes Assembly and Test of Semiconductor Components, Associated Equipment and Processes The Manufacturing of Semi-conductors. Semiconductor industry, Assembly and test of semiconductor components, associated equipment & process The Manufacturing of Semi-conductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes Assembly and Test of Semiconductor Components, associated equipment and processes. Assembly and Test of Semiconductor Components, Associated Equipment and Processes The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes The Manufacturing of Semi-conductors. The Manufacturing of Semi-conductors. Assembly and Test of Semiconductor Components, Associated Equipment and Processes Provision of saw cutting and grinding of metals in customer supplied form. The Design and Development, Manufacturing and Distribution of Drug Coated Sinus Stents. The provision of management and technical services in programmatic support, systems engineering, design and development, quality management and engineering support, service, systems support, technology management solutions to the Department ofDefense, government agencies, aerospace and commercial customers.
The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products, In-Vitro Diagnostic Devices for use in Genetic Testing of Various Hematological Disorders, and AssistedReproductive Products for In-Vitro Fertilization use.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Irvine Scientific
MD19.2686/A
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
Irvine Scientific
MD19.2686/B
Secondary
Santa Ana
CA
USA
ISO 13485/CMDCAS
Irvine Scientific - Ireland
MD19.4353
Single
Co. Wicklow
Ireland
I.S.EN ISO13485:2012
Ivantis, Inc.
MD19.4490
Single
Irvine
CA
USA
ISO 13485/CMDCAS
19.4404 19.4418
Single Single
San Jose Royal Oak
CA MI
USA USA
ISO 9001:2008 ISO 9001:2008
KAPP Surgical Instrument, Inc.
MD19.4432
Single
Warrensville Heights
OH
USA
I.S.EN ISO13485:2012
Katalyst Surgical, LLC
MD19.4648
Single
Chesterfield
MO
USA
ISO 13485/CMDCAS
Kentec Medical, Inc.
MD19.4996
Single
Irvine
CA
USA
ISO 13485:2003
Kimball Kimball Kimball Kimball
19.4409 19.4409/A 19.4409/C 19.4409/D
Primary Secondary Secondary Secondary
Jasper Jasper Jasper Salem
IN IN IN IN
USA USA USA USA
ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015
Kimball Electronics Inc. - Jasper
AS19.1504/A
Secondary
Jasper
IN
USA
AS 9100 - D
Manufacturing and Testing of Printed Circuit Board Assemblies (PCBA) for Aviation, Space and Defense Industries.
Kimball Electronics Inc. - Jasper
AS19.1504
Primary
Jasper
IN
USA
AS 9100 - D
Manufacturing and Testing of Printed Circuit Board Assemblies (PCBA) for Aviation, Space and Defense Industries.
Kimball Electronics, Inc. û Jasper
MD19.1504
Primary
Jasper
IN
USA
ISO 13485:2016
Kimball Electronics, Inc. û Jasper
MD19.1504/A
Secondary
Jasper
IN
USA
ISO 13485:2016
Kingston Technology International Ltd
27.4952
Single
Dublin 15
Ireland
ISO 27001:2013
KRI-Color, LLC
19.8061
Single
Sanford
ME
USA
ISO 9001:2015
Lake Region Medical
MD19.4406/A
Secondary
Chaska
MN
USA
Lake Region Medical
MD19.4406/B
Secondary
Chaska
MN
USA
Lake Region Medical
MD19.4406/C
Secondary
Chaska
MN
USA
Lake Region Medical
MD19.4406/D
Secondary
Chaska
MN
USA
Lake Region Medical
MD19.4406
Primary
Chaska
MN
USA
Lake Region Medical Ltd
14.0400HQ
Single
Co. Wexford
Ireland
Lake Region Medical Ltd
18.0118HQ
Single
Co Wexford
Ireland
Lake Region Medical Ltd.
MD19.3915
Single
New Ross
Lam Research Corporation Lam Research Corporation Lam Research Corporation
19.3276/C 14.0228/C 18.0228
Secondary Secondary Single
Villach Villach Fremont
COMPANY
JL Precision Jones Lang LaSalle
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Co. Wexford
Ireland
CA
Austria Austria USA Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products, In-Vitro Diagnostic Devices for use in Genetic Testing of Various Hematological Disorders, and AssistedReproductive Products for In-Vitro Fertilization use. The Design, Development, Manufacture, Contract Manufacture and Distribution of Medical Devices Consisting of Tissue Culture Products, In-Vitro Diagnostic Devices for use in Genetic Testing of Various Hematological Disorders, and AssistedReproductive Products for In-Vitro Fertilization use. The storage and distribution of medical devices consisting of tissue culture products. In Vitro Diagnostics Devices for use in Genetic Testing of Various Hematolgical Disorders and Assisted Reproductive Products for In Vitro Fertilization use. The Design, Manufacture and Distribution of Sterile Implantable Ophthalmic Devices for Treatment of Glaucoma. Precision Sheet Metal, CNC Machining and Custom Framing Delivery of Integrated Facilities Management Services at Client Facilities Design, Manufacture, Service and Distribution of Reusable Instruments and Surgical Accessories used for Cardiovascular and Orthopaedic procedures,Implantable Gastric Radiographic Markers, Small Joint Orthopaedic Prostheses Implants, and Sterile Surgical Securement Devices. The Design, Manufacture, and Distribution of Sterile and Non-Sterile Instruments and Accessories for Opthalmic, Neurosurgery, and General Surgery. Design, Manufacture, and Distribution of Enteral Feeding Tubes and Accessories, Infant ECG Electrodes, Temperature Probes and Probe Covers, and Infant Arm Boards The design, manufacture and sales of office furniture products and sub-assemblies. The design, manufacture and sales of office furniture products and sub-assemblies. The design, manufacture and sales of office furniture products and sub-assemblies. The design, manufacture and sales of office furniture products and sub-assemblies.
MD Scope: The Provision of Electronics Contract Manufacturing and Assembly Services for the Medical Industry.ISO9K Scope: An electronics manufacture service provider for contract manufacturing services for the computer, industrial, medical, public safety, telecommunications and transportation industries. MD Scope: The Provision of Electronics Contract Manufacturing and Assembly Services for the Medical Industry.ISO9K Scope: An electronics manufacture service provider for contract manufacturing services for the computer, industrial, medical, public safety, telecommunications and transportation industries. The ISMS applies to the assets and processes involved in KingstonÆs provision of packaging and distribution services to OEM manufacturers in accordance with the Statement of Applicability version 16 dated Feb 2017
Manufacture and Delivery of Silicone Dispersions MD: The Design and Development, Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile Guidewires for Vascular and Non-Vascular use, including Guidewires with Electrical Components, Intravascular Catheters, Stents, I.S.EN ISO13485:2012 StentDelivery Systems, Torque Devices, Stylets, Biopsy Instruments, Machined Components, and Custom Wire and Tube Products for Medical Applications. MD: The Design and Development, Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile Guidewires for Vascular and Non-Vascular use, including Guidewires with Electrical Components, Intravascular Catheters, Stents, I.S.EN ISO13485:2012 StentDelivery Systems, Torque Devices, Stylets, Biopsy Instruments, Machined Components, and Custom Wire and Tube Products for Medical Applications. MD: The Design and Development, Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile Guidewires for Vascular and Non-Vascular use, including Guidewires with Electrical Components, Intravascular Catheters, Stents, I.S.EN ISO13485:2012 StentDelivery Systems, Torque Devices, Stylets, Biopsy Instruments, Machined Components, and Custom Wire and Tube Products for Medical Applications. MD: The Design and Development, Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile Guidewires for Vascular and Non-Vascular use, including Guidewires with Electrical Components, Intravascular Catheters, Stents, I.S.EN ISO13485:2012 StentDelivery Systems, Torque Devices, Stylets, Biopsy Instruments, Machined Components, and Custom Wire and Tube Products for Medical Applications. MD: The Design and Development, Manufacture, Contract Manufacture, and Distribution of Sterile and Non-Sterile Guidewires for Vascular and Non-Vascular use, including Guidewires with Electrical Components, Intravascular Catheters, Stents, I.S.EN ISO13485:2012 StentDelivery Systems, Torque Devices, Stylets, Biopsy Instruments, Machined Components, and Custom Wire and Tube Products for Medical Applications. The design & development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac ISO 14001:2015 applications The design & development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral and cardiac OHSAS 18001:2007 applications The design & development, manufacture and distribution of sterile and non-sterile guidewires used in peripheral, cardiac and ISO 13485/CMDCAS urological applications. ISO 9001:2008 The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. ISO 14001:2004 The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. BS OHSAS 18001:2007 The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment.
01/18/18
CITY
STATE
Country
Scheme
19.3276/B 14.0228/B 19.3276/A 14.0228/A 14.0228 19.3276 19.4264 14.4886 19.4479
Profile Type Secondary Secondary Secondary Secondary Primary Primary Single Single Single
Tualatin Tualatin Livermore Livermore Fremont Fremont Modesto Hooks Uxbridge
OR OR CA CA CA CA CA TX MA
USA USA USA USA USA USA USA USA USA
ISO 9001:2008 ISO 14001:2004 ISO 9001:2008 ISO 14001:2004 ISO 14001:2004 ISO 9001:2008 ISO 9001:2008 ISO 14001:2004 ISO 9001:2008
19.4257
Single
Newport
NH
USA
ISO 9001:2008
LFI Inc.
AS19.4749
Single
Smithfield
RI
USA
AS 9100 - C
LFI Inc.
MD19.4749
Primary
Smithfield
RI
USA
I.S.EN ISO13485:2012
Libra Industries
MD19.4688
Single
Richardson
TX
USA
I.S.EN ISO13485:2012
Libra Industries
AS19.4688
Single
Richardson
TX
USA
AS 9100 - D
Life Instrument Corporation
MD19.4842
Single
Braintree
MA
USA
I.S.EN ISO13485:2012
Life Science Outsourcing, Inc.
MD19.4297
Single
Brea
CA
USA
I.S.EN ISO13485:2012
Life Sensing Instruments, Inc.
MD19.8064/A
Secondary
Manchester
TN
USA
ISO 13485:2003
Life Sensing Instruments, Inc.
MD19.8064/B
Secondary
Charlotte
NC
USA
ISO 13485:2003
Life Systems International
MD19.8064
Primary
Charlotte
NC
USA
ISO 13485:2003
Lilly Ming International, Inc. Linear & Metric Co
MD19.8021 19.4624
Single Single
Irvine Londonderry
CA NH
USA USA
ISO 13485:2003 ISO 9001:2015
COMPANY Lam Research Corporation Lam Research Corporation Lam Research Corporation Lam Research Corporation Lam Research Corporation Lam Research Corporation Lamar Tool & Die Casting, Inc. Lamb Depollution Lampin Corporation Latva Machine, Inc.
Log It syncreon
Registration Number
27.8031/C
Secondary
Logan Instruments Inc.
19.4518
Single
Everett
Lumen Dynamics
19.4911
Single
Ontario
Lumen Dynamics
14.4911
Single
Ontario
Lumitex Medical Devices, Inc.
MD19.4787/A
Secondary
Strongsville
Lumitex Medical Devices, Inc.
MD19.4787
Primary
Lumitex, Inc
MD19.4788/A
Lumitex, Inc.
The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The Design, Manufacture, Installation and Servicing of Semiconductor Wafer Fab Equipment. The production and distribution of aluminum and zinc die cast products. The Collection and Disposition of Automotive Liquids and Fuels. Manufacture of Precision Mechanical Components and Assemblies. Precision machining and turning facility specializing in complex components and assemblies from exotic material in bar stock, plate, casting and forging material for the Aerospace, Military and Commercial applications. Laser Cutting, Drilling, Welding and Engraving; Excluding Design Section 7.3 and Post Delivery Support 7.5.1.4 a,c,d,e The Contract manufacturing and machining of medical device components, and contract assembly and packaging of medical devices. ISO 13485 Scope: The Layout, Manufacture and Final Test of Printed Circuit Boards and Electromechanical Assemblies used for Medical Devices.9K Scope: The Layout, Manufacture and Final Test of Printed Circuit Boards and Electromechanical Assemblies. The Layout and Procurement of Printed Circuit Boards, Manufacture and Final Test of Printed Circuit Board Assemblies, and Electromechanical Assemblies for Medical, Aerospace and Commercial Devices. The Design, Manufacture, Service and Distribution of Reusable Hand-Held Surgical Instrumentation. CM SCOPE:Design, Manufacture and Distribution of Transfer Pin, Pump Transfer Sets and Extension Sets. MD Scope: Design, Manufacture, and Distribution of Transfer Pins, Pump Transfer Sets and Extension Sets. Contract Design and Development, ContractManufacture of Non-Active Invasive and Non-Invasive Surgical, and Active Electro-Medical Devices, and Distribution and Package Testing, Cleaning and Decontamination; including Contract Moist Heat Sterilization and Validation Services in accordancewith ISO 17665-1:2006 and Contract Ethylene Oxide Sterilization and Validation Services in accordance with ISO 11135:2007 . The Design, Manufacture, Installation and Servicing of Cardiopulmonary Patient Monitoring Systems, including Central Workstation, Monitoring and Diagnostic Software, and Wearable ECG Transmitters. The Design, Manufacture, Installation and Servicing of Cardiopulmonary Patient Monitoring Systems, including Central Workstation, Monitoring and Diagnostic Software, and Wearable ECG Transmitters. The Design, Manufacture, Installation and Servicing of Cardiopulmonary Patient Monitoring Systems, including Central Workstation, Monitoring and Diagnostic Software, and Wearable ECG Transmitters. The Manufacture of Hydrophobic Acrylic Polymer Materials for use in Intraocular Lenses Sales and Production of Machined Products The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
Germany
ISO 27001:2013
USA
ISO 9001:2008
Manufacture and Repair of Hand-Held Surgical Instruments for Various Surgical Applications.
Canada
ISO 9001:2008
Design and manufacture of precision light sources and delivery systems for use in photochemical and illumination applications.
Canada
ISO 14001:2004
Design and manufacture of precision light sources and delivery systems for use in photochemical and illumination applications.
OH
USA
ISO 13485:2003
Strongsville
OH
USA
ISO 13485:2003
Secondary
Strongsville
OH
USA
I.S.EN ISO13485:2012
MD19.4788
Primary
Strongsville
OH
USA
I.S.EN ISO13485:2012
19.4894
Single
Arlington
VA
USA
ISO 9001:2015
Lynch Medical Supplies (LMS) Ltd.
MD19.1933
Single
Co. Dublin
Ireland
I.S.EN ISO13485:2012
The manufacture and supply of non-sterile crepe and conforming bandages and the supply of related medical disposables.
M & M Qualtech Ltd
MD19.3726
Single
Co Galway
Ireland
I.S.EN ISO13485:2012
The Sub-Assembly Manufacture, Assembly and System Integration of Non-Invasive Medical Devices such as Brain Tissue Monitoring Systems, Printed Circuit Board Assemblies and Respiratory Products:The Manufacture of Medical Device Interface Cables and Power Supply Units.
Lunarline
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
36272 Niederaula
Scope
MA
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Design and Development, Production, Contract Manufacturing and Distribution of Sterile and Non-sterile Medical Illumination Devices and Non-sterile Phototherapy Devices. Design and Development, Production, Contract Manufacturing and Distribution of Sterile and Non-sterile Medical Illumination Devices and Non-sterile Phototherapy Devices. 13485 Scope: Design, Development, Production and Distribution of Medical Illumination Devices and Phototherapy Devices.9K Scope:The Design, Development, Manufacture and Sale of Electronics Backlighting, Medical Illumination Devices and Phototherapy Devices. 13485 Scope: Design, Development, Production and Distribution of Medical Illumination Devices and Phototherapy Devices.9K Scope: The Design, Development, Manufacture and Sale of Electronics Backlighting, Medical Illumination Devices, and Phototherapy Devices. Automation and delivery of cyber security and privacy services, training and products.
01/18/18
Registration Number
Profile Type
CITY
19.3726
Single
Co Galway
Maintech Maintech Manufacturing Technology Group
19.4637 19.4637/A 19.4817
Primary Secondary Single
Cranford Wallington Westfield
MAR COR Purification
MD19.4437
Primary
MAR COR Purification
MD19.4437/A
COMPANY
Country
Scheme
Ireland
ISO 9001:2008
NJ NJ MA
USA USA USA
ISO 9001:2008 ISO 9001:2008 ISO 9001:2015
Minneapolis
MN
USA
I.S.EN ISO13485:2012
Secondary
Plymouth
MN
USA
I.S.EN ISO13485:2012
MD19.4354
Single
Grand Rapids
MI
USA
I.S.EN ISO13485:2012
19.4501
Single
Chester
SC
USA
ISO 9001:2008
Mass Design
MD19.4584
Single
Nashua
NH
USA
I.S.EN ISO13485:2012
MASS Precision Mexico S de RL de CV
19.1435/B
Secondary
El Salto, Jalisco
Mexico
ISO 9001:2008
MASS Precision, Inc.
19.1435
Primary
San Jose
CA
USA
ISO 9001:2008
MASS Precision, Inc.
19.1435/C
Secondary
San Jose
CA
USA
ISO 9001:2008
MASS Precision, Inc.
MD19.1435/A
Single
Fremont
CA
USA
I.S.EN ISO13485:2012
Maxx Orthopedics, Inc.
MD19.4983
Single
Plymouth Meeting
PA
USA
I.S.EN ISO13485:2012
MC3, Inc.
MD19.4726
Single
Dexter
MI
USA
I.S.EN ISO13485:2012
Ireland
I.S.EN ISO13485:2012
USA USA Nothern Ireland Ireland USA
AS 9100 - C AS 9100 - C I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 ISO 13485:2003
Ireland
I.S.EN ISO13485:2012
M & M Qualtech Ltd.
Mar-Med Co. Marathon Abrasive Company, Inc
McKesson Ireland
STATE
Scope The Manufacture of Electronic Products and Wiring Harnesses. Supply Chain Management: including procurement, materials management, pick/pack ship, and customer order fulfillment IT Infrastructure Support Services IT Infrastructure Support Services Fabrication of metal goods for the commercial and industrial marketplace. Design, Manufacturing, Installation and Service of Solution Delivery Systems and Reverse Osmosis Systems used in Hemodialysis and Distribution of Filter Products and Cleaners/Sterilants used in Hemodialysis including Dispensing Equipment. Design, Manufacturing, Installation and Service of Solution Delivery Systems and Reverse Osmosis Systems used in Hemodialysis and Distribution of Filter Products and Cleaners/Sterilants used in Hemodialysis including Dispensing Equipment. The Design, Development, Manufacture and Distribution of Sterile Tourniquet Devices for Digit Surgery and Non-sterile Cast Protectors. Manufacture of Custom Hot Pressed, High Speed Grinding Wheels MD Scope: The Manufacture and Assembly of Printed Wiring Boards for the Medical Industry.ISO9K Scope: Layout, Fabrication and Assembly of Printed Circuit Boards Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal Components, Assemblies and ElectroMechanical Assemblies. Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal Components, Assemblies and ElectroMechanical Assemblies. Contract Design, Manufacturing, System Integration, Refurbishing and Testing of Metal Components, Assemblies and ElectroMechanical Assemblies. Contract Design, Manufacturing, System Integration and Testing of Metal Components, Assemblies and Electro-Mechanical Assemblies for (Non-Sterile) Medical Application. The Design and Development, Manufacturing, and Distribution of Orthopedic Implants and Re-Usable Surgical Instruments MD Scope: The Design and Development, Manufacture and Distribution of Medical Devices for Cardiovascular Applications, including Cannulae.CMDCAS Scope: The Design and Development, Manufacture and Distribution of Medical Devices for Cardiovascular Applications, including Cannulae. ISO 13485: The Manufacture and Distribution of Healthcare Software and Web-based Programmes used for Patient Monitoring, Diagnostic and Image Management. Precision Machining and Component Production Precision Machining and Component Production The supply, installation, maintenance, service and repair of medical instruments, systems and equipment. The supply, installation, maintenance, service and repair of medical instruments, systems and equipment. Specialized Sales, Logistics and Distribution of Medical Devices The design and development, manufacture and distribution of disinfection agents specifically intended for disinfecting medical devices.ISO9k: The design, development, manufacture and packing of effervesent tablets and granules, and the design, development and assembly of water disinfection devices. Manufacture and Distribution of Aerosol Delivery System Products. The Manufacturing of Metal and Plastic Medical and Dental Implants, Appliances and Tools. The Design, Manufacture and Distribution of Automated Systems for the Monitoring and Evaluation of Neonatal and Paediatric Heart Rate Variability. The Design and Development, Manufacture and Distribution of Non-Sterile Devices for the Trans-Rectal Measurement of Prostate Gland Volume.
MD19.3689
Single
Co Cork
AS19.8130/A AS19.8130 MD19.3987/1 MD19.3987HQ MD19.8011
Secondary Primary Secondary Primary Single
Cincinnati Cincinnati Kells Sycamore
Medentech
MD19.5492
Single
Wexford,
Medi/Nuclear Corporation, Inc. also Medical Device and Implants LLC
MD19.4950 MD19.4889
Single Single
Baldwin Park Lancaster
CA PA
USA USA
I.S.EN ISO13485:2012 ISO 13485:2003
Medical Predictive Science Corporation
MD19.4577
Single
Charlottesville
VA
USA
ISO 13485/CMDCAS
MedicaMetrix, Inc.
MD19.8040
Single
Lowell
MA
USA
EN ISO 13485:2012
Medicote
19.8054
Single
Bristol
RI
USA
ISO 9001:2015
Medicote
MD19.8054
Single
Bristol
RI
USA
I.S.EN ISO13485:2012
Medifill Ltd Medifill Ltd.
MD19.5398 19.5398
Single Single
Dublin 15 Dublin 15
Ireland Ireland
I.S.EN ISO13485:2012 ISO 9001:2008
Medivance Inc.
MD19.3373
Single
Louisville
USA
ISO 13485/CMDCAS
The Design, Manufacture, Servicing and Distribution of Non-Sterile Devices for Therapeutic Temperature Management.
McSwain Manufacturing Corporation McSwain Manufacturing Corporation MDI Medical Ltd. MDI Medical Ltd. MED Alliance Group, Inc.
OH OH AK Co. Meath IL
CO
The Provision of Surface Treatments, including Fluoropolymer Coatings, Anodizing, Hard Coating, Chromating and Passivation 13485 scope: The Provision of Surface Treatments for the Medical Device Components, including Anodizing and Passivation the Application of Fluropolymer coating9001 scope: The Provision of Surface Treatments, including Fluoropolymer Coatings, Anodizing, Hard Coating, Chromating and Passivation The Design, Manufacture and Distribution of Medical and Surgical Adhesives. The Manufacture and Supply of Bulk Adhesives
Medivators Inc.
MD19.2990
Primary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories, Sterilants, Detergents and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators, Water Filters and Endoscopic Irrigation Pumps and Insufflators. Provision of Hydrogen Peroxide/Peracetic Acid Contract Processing Services inAccordance with ISO 14937:2009.
Medivators Inc.
MD19.4716
Primary
Conroe
TX
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Medical Devices used in an Endoscopy Procedure and General Surgery including Disposable Valves, Sterile Tubing Sets, Endoscopy Cuff, Procedure Kits and related accessories.
Medivators Inc.
MD19.4716/B
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Medical Devices used in an Endoscopy Procedure and General Surgery including Disposable Valves, Sterile Tubing Sets, Endoscopy Cuff, Procedure Kits and related accessories.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Scope
Medivators Inc.
MD19.4716/A
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Medical Devices used in an Endoscopy Procedure and General Surgery including Disposable Valves, Sterile Tubing Sets, Endoscopy Cuff, Procedure Kits and related accessories.
Medivators Inc.
MD19.2990/B
Secondary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories, Sterilants and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators, Water Filters and Endoscopic Irrigation Pumps and Insufflators. Provision of Hydrogen Peroxide/Peracetic Acid Contract Processing Services inAccordance with ISO 14937:2009.
Medivators Inc.
MD19.2990/A
Secondary
Minneapolis
MN
USA
ISO 13485/CMDCAS
The Design, Manufacture, Distribution, Installation and Service of Automatic Endoscope Reprocessing Equipment Including Leak Tester Accessories, Sterilants and High Level Disinfectants,Dialyzer Reprocessing Systems, Hemodialysis Concentrates, Hemodialyzers, Hemofilters and Hemoconcentrators, Water Filters and Endoscopic Irrigation Pumps and Insufflators. Provision of Hydrogen Peroxide/Peracetic Acid Contract Processing Services inAccordance with ISO 14937:2009.
Medivators Inc.
MD19.4716/C
Secondary
Conroe
TX
USA
ISO 13485/CMDCAS
The Design and Development, Manufacture, and Distribution of Medical Devices used in an Endoscopy Procedure and General Surgery including Disposable Valves, Sterile Tubing Sets, Endoscopy Cuff, Procedure Kits and related accessories.
Medspira LLC
MD19.4639
Single
Minneapolis
MN
USA
ISO 13485/CMDCAS
The design, manufacture, and distribution of active manometry systems and catheters, magnetic resonance imaging accessories, and patient biofeedback monitors.
Medtrade Products Ltd
MD19.8123
Single
Cheshire
United Kingdom
I.S.EN ISO13485:2012
18.0102 14.0381
Single Single
Co. Galway Co. Galway
Ireland Ireland
OHSAS 18001:2007 ISO 14001:2015
MD19.3773
Primary
Santa Ana
USA
I.S.EN ISO13485:2012
MD & CMDCAS Scope: The design, manufacture and distribution of transcatheter tissue aortic valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic CryoCath LP
MD19.4906/D
Secondary
Pointe-Claire, Quebec
Canada
I.S.EN ISO13485:2012
The Design and Development, Manufacture and Distribution of Cardiac Ablation Systems, including Sterile Disposable Catheters and Guidewires, Service of Cardiac Ablation Instruments, and Distribution of Sheaths
Medtronic Mexico S. de R.L. de CV
MD19.3773/D
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
MD & CMDCAS Scope: The design, manufacture and distribution of transcatheter tissue aortic valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
MD19.3773/E
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
MD & CMDCAS Scope: The design, manufacture and distribution of transcatheter tissue aortic valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
MD19.3773/F
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
MD & CMDCAS Scope: The design, manufacture and distribution of transcatheter tissue aortic valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
MD19.3773/A
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
MD & CMDCAS Scope: The design, manufacture and distribution of transcatheter tissue aortic valve, delivery system, compression loading device and guide wires for use in cardiovascular diagnostic and interventional procedures.
Medtronic Mexico S. de R.L. de CV
MD19.4906/C
Secondary
Baja California
Mexico
I.S.EN ISO13485:2012
Medtronic, Inc.
MD19.4906/B
Secondary
Mounds View
MN
USA
I.S.EN ISO13485:2012
Medtronic, Inc.
MD19.4906
Primary
Minneapolis
MN
USA
I.S.EN ISO13485:2012
Mergon International
MD19.5141
Single
Co. Westmeath
Ireland
I.S.EN ISO13485:2012
MGS Manufacturing Group LTD
MD19.5354
Single
Co. Kildare
Ireland
I.S.EN ISO13485:2012
Microfabrica, Inc.
MD19.4440
Single
Van Nuys
Microsemi Ireland Microsemi Ireland Microsoft Operations Puerto Rico, LLC
AS19.4514 14.4514 19.4392
Single Single Single
Co Clare Co Clare Humacao
19.4322
Single
San Antonio
Microwave Components and Systems Inc.
AS19.4818
Single
Mid-State Machine Products
AS19.4474 19.4862 14.4712
Miramar Labs, Inc. Mobiquity, Inc.
COMPANY
Medtronic Medtronic Medtronic CoreValve LLC
Microteq Engineering, Inc.
Midwest Truck & Auto Parts, Inc. Mile Hi Foods
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
CA
CA
The Design and Development, Manufacture and Distribution of Silicone Wound Contact Layer (SWCL) Dressing Products The design and manufacture of medical devices. The environmental aspects for the design and manufacture of Cardiology Products
The Design and Development, Manufacture and Distribution of Cardiac Ablation Systems, including Sterile Disposable Catheters and Guidewires, Service of Cardiac Ablation Instruments, and Distribution of Sheaths The Design and Development, Manufacture and Distribution of Cardiac Ablation Systems, including Sterile Disposable Catheters and Guidewires, Service of Cardiac Ablation Instruments, and Distribution of Sheaths The Design and Development, Manufacture and Distribution of Cardiac Ablation Systems, including Sterile Disposable Catheters and Guidewires, Service of Cardiac Ablation Instruments, and Distribution of Sheaths The manufacture of blow moulded components and component assembles for the medical device industry.ISO 9K: The technical moulding and assembly of automotive, medical and industrial products. Contract Moulding and Manufacture of components for the Medical Device Industry.ISO9K: Contract manufacture of injection moulded components and mould tool maintenance and repair. MD 13485 only: Manufacture and distribution of miniature metal medical device parts and components.ISO 9001 only: Manufacture and distribution of miniature metal parts and components. Screening and Supply of High Reliability Discrete Semiconductor Component. Screening and Supply of High Reliability Discrete Semiconductor Component. Manufacture of Optical Media CD/DVD ROM and Physical USB
USA
ISO 13485:2003
Ireland Ireland Puerto Rico
AS 9100 - C ISO 14001:2004 ISO 9001:2015
TX
USA
ISO 9001:2008
Manufacturing Facility providing Precision Machining, Sheet Metal, Fabrication, Wire Harness, Welding, Painting and Electrical/Mechanical Assemblies for Department of Defense, Aerospace, Energy, Semiconductor and Oil Industry.
Westborough
MA
USA
AS 9100 - D
Design and manufacturing of microwave components and systems for aerospace, military and commercial industries.
Single
Winslow
ME
USA
AS 9100 - C
Provider of machined products and related services (e.g. weld and NDE) to a customer design and specified requirement.
Single Single
Chicago Denver
IL CO
USA USA
ISO 9001:2015 ISO 14001:2004
MD19.4519
Single
Santa Clara
CA
USA
ISO 13485/CMDCAS
MD19.8055
Single
Waltham
MA
USA
I.S.EN ISO13485:2012
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Wholesale Supplier of Aftermarket Truck and Automotive Components and Fabricated Assemblies Distribution of food The Design, Manufacture, Distribution and Servicing of Microwave/RF Energy Generation Systems, Electro-Mechanical Applicators, and related Sterile Accessories for the treatment of Dermatologic Disorders. The Provision of Contract Design and Development Services for Mobile Medical Software Applications
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
MD19.4664/A
Single
Milpitas
CA
USA
ISO 13485:2003
MD19.0819
Single
Co. Donegal
Ireland
I.S.EN ISO13485:2012
Monobind Inc.
MD19.4585/A
Secondary
Lake Forest
CA
USA
I.S.EN ISO13485:2012
Monobind Inc.
COMPANY Modulus Inc.
Moll Industries Ireland Ltd
Scope 9K Scope: Contract Design, Prototyping Manufacture and Service of General Commercial Electronic Devices and Electronic Sub-Assemblies for Medical Devices.ISO 13485 Scope: Contract Design and Development, and Manufacturing of NonImplantable Medical Devices and Related Components and Subsystems. The manufacture, assembly and packaging of injection molded medical devices and micro molded components.ISO9K Scope: The manufacture, assembly and packaging of injection molded medical devices, pharmaceutical packaging and micro molded components. The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device Immunoassays, and Related Reagent Products and Equipment The Design, Manufacture and Distribution of In-Vitro Diagnostic Medical Device Immunoassays, and Related Reagent Products and Equipment The Design and Manufacture of Microelectronic Assemblies. Design, Manufacture, and Servicing of AC & DC Electrical Switchgear and Switchboards, Circuit Breakers, Bus Duct, Relay Panels, Power Control Centers, Metered Service Pedestals, Panel Boards, Battery Analysis, Enclosures, Rectifiers, Inverters, andRelated Equipment. Provider of Precision Metal Fabrication, Secondary Assembly and Design Engineering Services. The Design, Manufacture and Sales of Office Furniture Products and Sub-Assemblies. The Design, Manufacture and Sales of Office Furniture Products and Sub-Assemblies. The Design, Manufacture and Sales of Office Furniture Products and Sub-Assemblies. The Design, Manufacture and Sales of Office Furniture Products and Sub-Assemblies. The Design, Manufacture and Sales of Office Furniture Products and Sub-Assemblies. MD Scope: Contract Manufacturing, Assembly, and Packaging of Medical DevicesISO9K Scope: Design, Manufacturing and Supply of Packaging for the Healthcare, Electronic and Pharmaceutical Industries.
MD19.4585
Primary
Lake Forest
CA
USA
I.S.EN ISO13485:2012
Monzite d.b.a. Impellimax
19.4683
Single
Nashua
NH
USA
ISO 9001:2015
Myers Controlled Power, LLC
19.4209
Single
North Canton
OH
USA
ISO 9001:2015
National Fabtronix, Inc. National Office Furniture National Office Furniture-Danville National Office Furniture-Fordsville National Office Furniture-Jasper 11th Av National Office Furniture-Santa Claus
19.8006 19.4408 19.4408/D 19.4408/B 19.4408/C 19.4408/A
Single Primary Secondary Secondary Secondary Secondary
Hayward Jasper Danville Fordsville Jasper Santa Claus
CA IN KY KY IN IN
USA USA USA USA USA USA
ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015
Nelipak Holdings Ireland Ltd
MD19.5447
Single
Galway
Ireland
I.S.EN ISO13485:2012
NeoTract, Inc.
MD19.4512/A
Secondary
Livermore
CA
USA
I.S.EN ISO13485:2012
MD: The Design, Manufacture and Distribution of Implantable Medical Devices in the area of Urology, and the Distribution of Related Urology Procedure Accessories.CMDCAS: The Design, Manufacture and Distribution of Implantable Medical Devices for the treatment of Benign Prostatic Hyperplasia, and the Distribution of Related Urology Procedure Accessories.
NeoTract, Inc.
MD19.4512/B
Secondary
Livermore
CA
USA
I.S.EN ISO13485:2012
MD: The Design, Manufacture and Distribution of Implantable Medical Devices in the area of Urology, and the Distribution of Related Urology Procedure Accessories.CMDCAS: The Design, Manufacture and Distribution of Implantable Medical Devices for the treatment of Benign Prostatic Hyperplasia, and the Distribution of Related Urology Procedure Accessories.
NeoTract, Inc.
MD19.4512
Primary
Pleasanton
CA
USA
I.S.EN ISO13485:2012
MD: The Design, Manufacture and Distribution of Implantable Medical Devices in the area of Urology, and the Distribution of Related Urology Procedure Accessories.CMDCAS: The Design, Manufacture and Distribution of Implantable Medical Devices for the treatment of Benign Prostatic Hyperplasia, and the Distribution of Related Urology Procedure Accessories.
NeoTract, Inc.
MD19.4512/C
Secondary
Pleasanton
CA
USA
I.S.EN ISO13485:2012
MD: The Design, Manufacture and Distribution of Implantable Medical Devices in the area of Urology, and the Distribution of Related Urology Procedure Accessories.CMDCAS: The Design, Manufacture and Distribution of Implantable Medical Devices for the treatment of Benign Prostatic Hyperplasia, and the Distribution of Related Urology Procedure Accessories.
MD19.4733
Single
Ventura
CA
USA
I.S.EN ISO13485:2012
The design, manufacture, distribution and service of laryngeal surface electrodes, nerve location devices and software, surface electrodes, stimulation instruments, and surgical devices used for nerve monitoring in head and neck surgery.
Nikkiso Cryo Incorporated
19.4933
Primary
North Las Vegas
NV
USA
Nikkiso Cryo Incorporated
14.4933
Primary
North Las Vegas
NV
USA
Nikkiso Cryo Incorporated
18.4933
Primary
North Las Vegas
NV
USA
Nikkiso Cryo Incorporated
19.4933/A
Secondary
Las Vegas
NV
USA
Nikkiso Cryo Incorporated
14.4933/A
Secondary
Las Vegas
NV
USA
Nikkiso Cryo Incorporated
18.4933/A
Secondary
Las Vegas
NV
USA
Nomax Inc. Norben Company, Inc.
MD19.4759 19.4559
Single Single
St. Louis Willoughby
MO OH
USA USA
North American Rescue, LLC
MD19.8068
Single
Greer
SC
USA
Northern Clearing Inc. Northern Clearing Inc. Northern Clearing Inc. Northern Lenses
19.4524 14.4524 18.4524 MD19.8104
Single Single Single Single
Ashland Ashland Ashland Manchester
WI WI WI
USA USA USA UK
NovaBay Pharmaceuticals, Inc.
MD19.4867
Single
Emeryville
CA
USA
Novation iQ LLC NSI Health Systems, LLC Nypro Ltd
19.8063 MD19.8030 MD19.3539
Single Single Single
Lenexa Centennial Waterford
KS CO
USA USA Ireland
Neurovision Medical Products, Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both commerical and off-shore terminals, to include marine shipping. Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both ISO 14001:2004 commerical and off-shore terminals, to include marine shipping. Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both OHSAS 18001:2007 commercial and off-shore terminals, to include marine shipping. Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both ISO 9001:2008 commerical and off-shore terminals, to include marine shipping. Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both ISO 14001:2004 commerical and off-shore terminals, to include marine shipping. Design, Manufacture and Testing of Cryogenic pumps for the Energy Sector. Primary LNG and LPG pumps for both OHSAS 18001:2007 commercial and off-shore terminals, to include marine shipping. I.S.EN ISO13485:2012 Manufacture and distribution of sterile diagnostic ophthalmic strips. ISO 9001:2015 Distributor of Food and Chemical Ingredients for Pharmaceutical, Food/Nutrition and Electronic Industries. The Design, Development, Manufacture and Distribution of Sterile Needle, Catheter System for Emergency use in the ISO 13485/CMDCAS treatment of Tension Pneumothorax, and Sterile Fabric Based Trauma Dressings ISO 9001:2015 The support of right-of-way land clearing, access, reclamation, and site work. ISO 14001:2015 The support of right-of-way land clearing, access, reclamation, and site work. BS OHSAS 18001:2007 The support of right-of-way land clearing, access, reclamation, and site work. I.S.EN ISO13485:2012 The Manufacture and Distribution of Contact Lenses. The Design and Development, Manufacture, and Distribution of Medical Devices for Skin and Wound Cleansing, and for ISO 13485/CMDCAS Contact Lens Cleansing. ISO 9001:2015 The Manufacture, Lamination, and Fabrication of Polymers and Related Products. ISO 13485:2003 Design, Manufacture and Distribution of Surgical Retractors, Associated Blade Systems and Surgical Instruments. ISO 13485:2016 MD & ISO9K Scope: The Manufacture, Assembly, and Test of Injection Moulded Components and Assemblies. ISO 9001:2008
01/18/18
Registration Number
Profile Type
CITY
Nypro Ltd
MD19.2859
Single
Co. Wicklow
ODC Industries OFS Fitel, LLC OFS Fitel, LLC OFS Fitel, LLC Operational Technologies Corporation Operational Technologies Corporation Operational Technologies Corporation Operational Technologies Corporation Operational Technologies Corporation Operational Technologies Corporation
MD19.8106 TL19.8141/A TL19.8141 TL19.8142 14.4707 18.4707 18.4707/A 19.4707 19.4707/A 14.4707/A
Single Secondary Primary Single Primary Primary Secondary Primary Secondary Secondary
Norcross Carrollton Carrollton San Antonio San Antonio San Antonio San Antonio San Antonio San Antonio
OPKO Diagnostics LLC
MD19.4485
Single
OpTech Enterprise Solutions, LLC
TL19.4826/B
OpTech Enterprise Solutions, LLC
COMPANY
Country
Scheme
Ireland
I.S.EN ISO13485:2012
GA GA GA TX TX TX TX TX TX
France USA USA USA USA USA USA USA USA USA
I.S.EN ISO13485:2012 TL 9000 R5.5/R5.0 TL 9000 R5.5/R5.0 TL 9000 R5.5/R5.0 ISO 14001:2015 BS OHSAS 18001:2007 BS OHSAS 18001:2007 ISO 9001:2015 ISO 9001:2015 ISO 14001:2015
Woburn
MA
USA
I.S.EN ISO13485:2012
Secondary
Laredo
TX
USA
TL 9000 R6.0/R5.0
TL19.4826/C
Secondary
Yuma
AZ
USA
TL 9000 R6.0/R5.0
OpTech Enterprise Solutions, LLC
TL19.4826/D
Secondary
Sonora C.P.
Mexico
TL 9000 R6.0/R5.0
OpTech Enterprise Solutions, LLC
TL19.4826/F
Secondary
Laredo, Tamaulipas
Mexico
TL 9000 R6.0/R5.0
LLC LLC LLC LLC LLC LLC LLC LLC LLC LLC
14.4826 14.4826/B 14.4826/C 14.4826/D 14.4826/F 18.4826 18.4826/B 18.4826/C 18.4826/D 18.4826/F
Primary Secondary Secondary Secondary Secondary Primary Secondary Secondary Secondary Secondary
San Antonio Laredo Yuma Sonora C.P. Laredo, Tamaulipas San Antonio Laredo Yuma Sonora C.P. Laredo, Tamaulipas
TX TX AZ
USA USA USA Mexico Mexico USA USA USA Mexico Mexico
ISO 14001:2015 ISO 14001:2015 ISO 14001:2015 ISO 14001:2015 ISO 14001:2015 BS OHSAS 18001:2007 BS OHSAS 18001:2007 BS OHSAS 18001:2007 BS OHSAS 18001:2007 BS OHSAS 18001:2007
OpTech Enterprise Solutions, LLC
TL19.4826
Primary
San Antonio
TX
USA
TL 9000 R6.0/R5.0
Ortronics, Inc.
19.4619/C
Secondary
Dayton
OH
USA
ISO 9001:2015
Ortronics, Inc.
19.4619/B
Primary
Moraine
OH
USA
ISO 9001:2015
Ortronics, Inc.
19.4619
Secondary
Hickory
NC
USA
ISO 9001:2015
Our Lady's Hospital
MD19.8079
Single
Ireland
I.S.EN ISO13485:2012
Ovelle Ltd
MD19.4827
Single
Co. Louth
Ireland
I.S.EN ISO13485:2012
Owens & Minor Distribution, Inc.
MD19.4536/A
Secondary
Ontario
CA
USA
I.S.EN ISO13485:2012
Owens & Minor Distribution, Inc.
MD19.4536
Primary
Louisville
KY
USA
I.S.EN ISO13485:2012
19.4916
Single
Mansfield
OH
USA
ISO 9001:2008
Pacific Biosciences
MD19.4969/B
Secondary
Menlo Park
CA
USA
ISO 13485:2003
Pacific Biosciences
MD19.4969
Primary
Menlo Park
CA
USA
ISO 13485:2003
Pacific Biosciences
MD19.4969/A
Secondary
Menlo Park
CA
USA
ISO 13485:2003
Pacific Biosciences
MD19.4969/C
Secondary
Menlo Park
CA
USA
ISO 13485:2003
Pacific Biosciences
MD19.4969/D
Secondary
Menlo Park
CA
USA
ISO 13485:2003
Pantronix Corporation
MD19.1520
Single
Fremont
CA
USA
I.S.EN ISO13485:2012
Paradyne Medical Products, Inc
MD19.8103
Single
Brea
CA
USA
I.S.EN ISO13485:2012
OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions, OpTech Enterprise Solutions,
Oxyrase Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
TX TX AZ
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope MD Scope: The Contract Design and Development, Manufacture, Automated Assembly and Testing of Injection Moulded Components and Sub-assemblies.ISO9K Scope: The Contract Manufacture, Automated Assembly and Testing of Injection Moulded Components and Sub-assemblies. The Design, Manufacture and Distribution of Intraocular Lens Injector Systems. Design and Manufacture of Fiber Optic Apparatus Design and Manufacture of Optical Connectivity Solutions Design and Manufacture of Fiber Optic Cable Supply Chain Management Services and Warehousing Supply Chain Management Services and Warehousing Supply Chain Management Services and Warehousing Supply Chain Management Services and Warehousing Supply Chain Management Services and Warehousing Supply Chain Management Services and Warehousing The design, development, manufacture, and distribution of in-vitro diagnostic devices including reagents, calibrators, control materials, kits, instruments, and systems for the determination and evaluation of biomarkers in the areas of oncology andendocrinology. TL9000-H, V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain Management Services TL9000-H, V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain Management Services TL9000-H, V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain Management Services TL9000-H, V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services Supply Chain Management Services TL9000-H, V Scope: Supply Chain Management Services for the following product categories: 7.4 Repair Service, 7.7.5.1 Logistical Service, Third Party.ISO9K Scope: Supply Chain Management Services The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking industries. The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking industries The design, manufacture, and distribution of fiber optic, copper, and audio/video cable assemblies for the telecommunications and data networking industries The provision of decontamination and sterilization services for Re-Usable Medical Devices. Design, manufacture and distribution of non-medicated skin creams and the contract manufacture of non-medicated skin creams. ISO 13485 scope: Distribution, Logistics, Repackaging, Relabeling, Inspection, and Release for Medical Device Companies.ISO 9001 scope: Distribution, Logistics, Repackaging, Relabeling, Inspection, and Release for Medical Device Companies and Life Science Companies. ISO 13485 scope: Distribution, Logistics, Repackaging,Relabeling, Inspection, and Release for Medical Device Companies.ISO 9001 scope: Distribution, Logistics, Repackaging, Relabeling, Inspection, and Release for Medical Device Companies and Life Science Companies. Design, Manufacture and Distribute plated agar for microbial testing and enzyme suspension. The Design, Development, Manufacture, Distribution, Installation and Servicing of DNA Sequencing, Instruments, Reagents and Software for In-Vitro Diagnostic Medical Devices.truments, Reagents and Software for in-vitro diagnostic medical devices.Site Activites: Manufacturing The Design, Development, Manufacture, Distribution, Installation and Servicing of DNA Sequencing Instruments, Consumable and Software for In-Vitro Diagnostic Medical Devices.Site Activities: Administration The Design, Development, Manufacture, Distribution, Installation and Servicing of DNA Sequencing, Instruments, Reagents and Software for In-Vitro Diagnostic Medical Devices.Site Activities: Manufacturing The Design, Development, Manufacture, Distribution, Installation and Servicing of DNA Sequencing, Instruments, Reagents and Software for In-Vitro Diagnostic Medical Devices.Site Activities: Design The Design, Development, Manufacture, Distribution, Installation and Servicing of DNA Sequencing, Instruments, Reagents and Software for In-Vitro Diagnostic Medical Devices.Site Activities: Manufacturing The assembly, packaging and reliability testing of semiconductor devices, printed circuit boards and electronic systems for medical devices.ISO 9k: The assembly, packaging and reliability testing of semiconductor devices, printed circuit boards and electronic systems. Contract Design, Manufacture, and Distribution of Non-Active Medical Devices.
01/18/18
Parametric Technology (Shanghai) Parametric Technology (Shanghai) Parametric Technology (UK) Ltd. Parametric Technology GmbH Parametric Technology GmbH -Sindelfingen Parametric Technology India Pvt Ltd Parametric Technology SA Paricon Technologies Corporation
19.1192/R 19.1192/H 19.1192/C 19.1192/D 19.1192/K 19.1192/P 19.1192/E 19.4849
Profile Type Secondary Secondary Secondary Secondary Secondary Secondary Secondary Single
Parsagen Diagnostics, Inc.
MD19.4922
Single
Boston
MA
USA
I.S.EN ISO13485:2012
Passy-Muir, Inc.
MD19.3008
Single
Irvine
CA
USA
ISO 13485/CMDCAS
PAUL JABOULET AINE
14.4965
Single
DROME 26600
France
ISO 14001:2004
PAUL JABOULET AINE
19.4965
Single
DROME 26600
France
ISO 9001:2008
VA
USA
ISO 9001:2008
VA CA
United Kingdom Hong Kong South Africa USA USA
ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2008
COMPANY
PCCW Global
Registration Number
CITY
STATE
Country
Scheme
Gurgaon Aix-en-Provence, Cedex 03 Taunton
MA
China China United Kingdom Germany Germany India France USA
ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2015
Shanghai Farnborough Unterschleissheim
19.4492
Single
Herndon
19.8050/B 19.8050/C 19.8050/A 19.805 19.4802
Secondary Secondary Secondary Primary Single
London Quarry Bay
Penumbra Europe GmbH
MD19.4277/C
Secondary
13507 Berlin
Penumbra, Inc.
MD19.4277/E
Secondary
Alameda
CA
USA
Penumbra, Inc.
MD19.4277/D
Secondary
Livermore
CA
USA
Penumbra, Inc.
MD19.4277/B
Secondary
Alameda
CA
USA
Penumbra, Inc.
MD19.4277/A
Secondary
Alameda
CA
USA
Penumbra, Inc.
MD19.4277
Primary
Alameda
CA
USA
Penumbra, Inc.
MD19.4277/F
Secondary
Livermore
CA
USA
PerkinElmer
18.4411/B
Secondary
Billerica
MA
USA
PerkinElmer
14.4411/B
Secondary
North Billerica
MA
USA
PerkinElmer
19.4441
Single
Shelton
CT
USA
PerkinElmer
14.4441
Single
Shelton
CT
USA
PerkinElmer
18.4441
Single
Shelton
CT
USA
PerkinElmer
19.8029
Primary
Shelton
CT
PerkinElmer (India) Pvt Ltd.
19.4783
Primary
Maharashtra
PerkinElmer (Schweiz) AG
19.4502
Single
PCCW Global Inc. PCCW Global Inc. PCCW Global Inc. PCCW Global Inc. Pega Precision Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Herndon Morgan Hill
Germany
USA India Switzerland Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope Development and delivery of technical support for PTC software products The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products The development and delivery of technical support for PTC software products. Design and manufacture of high performance separable interconnection products. The Design, Manufacture and Distribution of In-Vitro Diagnosis Tests, Controls, and Accessories for Assessing the Risk of Preterm Birth. The Design, Manufacture and Distribution of Tracheostomy and Ventilator swallowing and speaking valves. Vine Growing, Purchase of Wine and Grapes, Protected Designation of Origin (PDO) Wine Making and Elaboration, Packaging, Storage, and Shipping Vine Growing, Purchase of Wine and Grapes, Protected Designation of Origin (PDO) Wine Making and Elaboration, Packaging, Storage, and Shipping Maintenance and Operations for a Global International Broadband Data and IP services, and Customized Network Services.
Network Project Management Activities Network Project Management Activities Network Project Management Activities Network Project Management Activities Precision sheet metal and machining job shop specializing in prototype and production. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. The Design, Manufacture, and Distribution of Endovascular Implants for the Treatment of Aneurysms, Catheters, Guidewires, Introducer Sheaths and related Accessories for Neurological and Peripheral Intravascular Access,Diagnosis, and Treatment. I.S.EN ISO13485:2012 The Design, Manufacture, Distribution and Service of Active Aspiration Systems and related Accessories. Distribution of Neurosurgical and Intravascular Access and Treatment Devices. Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Diagnostic and BS OHSAS 18001:2007 Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, andCustom Membranes Kits and Reagents as well as Assay Development and Compound Screening Services. Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Diagnostic and ISO 14001:2015 Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, andCustom Membranes Kits and Reagents as well as Assay Development and Compound Screening Services. The design, development, and manufacture of ICPMS, GCMS, LCMS, HPLC systems including the distribution of OEM ISO 9001:2015 analytical instruments, accessories, and consumables. The Design, Development, Manufacture and Service of Analytical Instruments and Systems, including Associate Hardware and ISO 14001:2004 Consumables. The Design, Development, Manufacture and Service of Analytical Instruments and Systems, including Associated Software OHSAS 18001:2007 and Consumables. ISO 9001:2008 Asset Management, Field Service, Relocation and Technical Support of Laboratory Equipment The Sales and Services of Discovery, Analytical & Diagnostic Instrumentation and Systems, Accessories, Spares Parts, ISO 9001:2015 Consumables, Reagents and Diagnostics Kits in India ISO 9001:2008 Sales, Support and Service of Instruments used in Chemical and Biological Laboratories.
01/18/18
Registration Number
Profile Type
CITY
PerkinElmer - LabMetrix Division
19.4459
Single
Villepinte
PerkinElmer - LAS
18.4411
Primary
Boston
PerkinElmer Cellular Technologies German
19.4931
Single
Hamburg
Germany
PerkinElmer de MΘxico
19.8069
Single
Mexico City
Mexico
ISO 9001:2015
Commercialization of scientific equipment, accessories and consumables for research, industry, health and environment. Maintenance, services, training and related services.Comercializaci≤n de equipos cientφficos, accesorios y consumibles para investigaci≤n, industria, salud y medio ambiente. Servicios de mantenimiento, capacitaci≤n y servicios relacionados.
PERKINELMER ESPA╤A S.L.
19.4971
Single
Madrid 28760
Spain
ISO 9001:2008
Distribution of scientific equipments, accessories and consumables for the research, industry, health and environmental sectors. Provision of maintenance, training and related services.COMERCIALIZACI╙N DE EQUIPOS CIENT═FICOS, DE ACCESORIOS Y DE CONSUMIBLES PARA LOS SECTORES DE INVESTIGACI╙N, INDUSTRIA, SALUD Y MEDIOAMBIENTE.PRESTACI╙N DE SERVICIOS DE MANTENIMIENTO, FORMACI╙N Y SERVICIOS ASOCIADOS.
PerkinElmer Health Sciences B.V.
MD19.5541
Single
TH Groningen
The Netherlands
I.S.EN ISO13485:2012
PerkinElmer Health Sciences Inc.,
MD19.4443/A
Secondary
Waltham
COMPANY
PerkinElmer Health Sciences Pvt. Ltd.
STATE
Country France
MA
MA
USA
USA
19.4828
Single
Chennai
MD19.4711
Single
Greenville
SC
USA
PerkinElmer Inc.
19.4411
Primary
Boston
MA
USA
PerkinElmer Inc.
19.4411/B
Secondary
North Billerica
MA
USA
PerkinElmer Inc.
14.4411
Primary
Boston
MA
USA
PerkinElmer Informatics PerkinElmer Ireland Ltd
19.4978 19.4462
Single Single
Waltham Dublin
MA
USA Ireland
PerkinElmer Italia SpA
19.4458
Single
Milano
Italy
PerkinElmer Italia SpA
14.4458
Primary
Milan
Italy
PerkinElmer Italia SpA
18.4458
Secondary
Milan
Italy
PerkinElmer LAS (Germany) GmbH
19.4456
Single
Rodgau
Germany
PerkinElmer Llantrisant PerkinElmer Llantrisant PerkinElmer Llantrisant
19.4444 14.4444 18.4444
Single Single Single
Llantrisant Llantrisant Llantrisant
United Kingdom United Kingdom United Kingdom
PerkinElmer Ltd.
19.4452
Single
Beaconsfield
United Kingdom
PERKINELMER N V
19.8109
Single
ZAVENTEM, 1930
BELGIUM
19.4470/A
Secondary
Villepinte
France
PerkinElmer Health Sciences, Inc.
PerkinElmer SAS
PerkinElmer SAS
19.447
Primary
PERKINELMER SINGAPORE PTE. LTD.
14.4445
Single
Singapore
PERKINELMER SINGAPORE PTE. LTD.
18.4445
Single
Singapore
MD19.4445
Single
Singapore
19.4964
Single
PerkinElmer Singapore Pte. Ltd. PerkinElmer South Africa (Pty) Ltd ** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Villebon SUR YVETTE
Tamil Nadu, India
Midrand, Gauteng 1686
France
South Africa Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scheme
Scope
Development of Qualification Service of Laboratory Instrumentation-Conception, Development, Production and Calibration of Measuring Systems and Laboratory Equipment. The Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Diagnostic and BS OHSAS 18001:2007 Research Detection Systems (kits) and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kits and Reagents as wellas Assay Development and Compound Screening Services. The design and development of analytical and detection systems, the manufacture of automated systems and test samples, the ISO 9001:2008 provision of technical and application support and training for those systems. ISO 9001:2015
Manufacture and distribution of reagents for DNA/RNA isolation. The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic instruments and ISO 13485/CMDCAS software used in the diagnosis and monitoring of cancer, fertility, endocrine disorders and in the management of maternalhealth screening, neonatal screening, prenatal screening and as an aid in diagnosis. Screening and Confirmatory Tests that Relates to Indicators for Human Genetic Diseases Focused on Fetal, Maternal and ISO 9001:2015 Newborn Domain I.S.EN ISO13485:2012 Design, manufacture and supply of specialized filter paper devices The Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Diagnostic and ISO 9001:2015 Research Detection Systems (kits) and Reagents, Molecular Biology Kits and Reagents,and Custom Membranes, Kits and Reagents as well as Assay Development and Compound Screening Services. Design, Manufacture and Distribution of Radiolabeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, ISO 9001:2015 Microspheres, Diagnostic and Research Detection Systems (Kits) and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kitand Reagents The Design and Manufacture of Radio Labeled Specialty Chemicals, Non-labeled Analogues, Radionuclides, Diagnostic and ISO 14001:2015 Research Detection Systems (kits) and Reagents, Molecular Biology Kits and Reagents, and Custom Membranes Kits and Reagents as wellas Assay Development and Compound Screening Services. ISO 9001:2015 Software Product Design, Development, Testing, Release and Customer Support Related Activities ISO 9001:2015 Supply, Service and Support of Laboratory Equipment Trading, installation, service assistance, application support and training for laboratory instrumentation for R&D and analytical ISO 9001:2015 controls. Trading, Installation, Service Assistance, Application Support and Training for Laboratory Instrumentation for R&D and ISO 14001:2004 Analytical Controls. Trading, Installation, Service Assistance, Application Support and Training for Laboratory Instrumentation for R&D and BS OHSAS 18001:2007 Analytical Controls. ISO 9001:2015
The Sales and Service of Analytical Instrumentation, Including Consumables and the Provision of Technical Education.
ISO 9001:2008 The manufacture of analytical instruments and systems. ISO 14001:2004 The manufacture of analytical instruments and systems. BS OHSAS 18001:2007 The manufacture of analytical instruments and systems. Installation and servicing of analytical instruments and systems including OneSource multi-vendor services and the provision of ISO 9001:2008 customers training. Installation, Qualification, Preventive and Corrective Maintenance of Analytical Instrumentation for R&D and Analytical Controls ISO 9001:2015 as well as Laboratory Asset Management in Benelux Countries
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research, industry, health and environmental sectors. Service provider for maintenance, qualification, training and other related services.Commercialisation dÆΘquipements scientifiques, dÆaccessoires et de consommables pour les secteurs de la recherche, de lÆindustrie, de la santΘ et de lÆenvironnement. RΘalisation de prestations de maintenance, de qualification, de formation et deservices associΘs.
ISO 9001:2008
Marketing and sales of scientific equipment, accessories and consumables for the research, industry, health and environmental sectors. Service provider for maintenance, qualification, training and other related services.Commercialisation dÆΘquipements scientifiques, dÆaccessoires et de consommables pour les secteurs de la recherche, de lÆindustrie, de la santΘ et de lÆenvironnement. RΘalisation de prestations de maintenance, de qualification, de formation et deservices associΘs.
Research and Development, Sales, Service and Manufacture of Analytical Science Instruments. Manufacture of Life Science Technology Instruments. Research and Development, Sales, Service and Manufacture of Analytical Science Instruments. Manufacture of Life Science BS OHSAS 18001:2007 Technology Instruments. ISO13485: The Design, Development and Manufacture of Atomic Spectroscopy and Gamma Counting Instruments and I.S.EN ISO13485:2012 Systems for Clinical Applications and/or In Vitro Diagnostic use.ISO9K: The Design, Development and Manufacture of Analytical and Detection Systems, and Manufacture of Plate Reader Systems ISO 9001:2008 Sale and service of analytical equipment, spare parts and consumables ISO 14001:2004
01/18/18
PermeaDerm Inc.
MD19.8113
Profile Type Single
Phardiag Ltd
MD19.3183
Single
Co. Clare
19.3145
Single
Sturbridge
PHOTONIS USA, Pennsylvania, Inc.
19.102
Single
Piconics, Incorporated
19.4329
Single
pNeo LLC
MD19.4982
Single
Portable Therapeutix, LLC PORTAL INSTRUMENTS, INC. Power-Sonic S de R.L de C.V
MD19.4892 MD19.8046 19.3594
Preceptis Medical
COMPANY
Registration Number
CITY
STATE
Carlsbad
CA
Country
Scheme
Scope
USA
I.S.EN ISO13485:2012
Ireland
I.S.EN ISO13485:2012
MA
USA
ISO 9001:2015
Lancaster
PA
USA
ISO 9001:2015
Tyngsboro
MA
USA
ISO 9001:2008
Azle
TX
USA
I.S.EN ISO13485:2012
Single Single Single
Stafford Cambridge Tijuana B.C.
TX MA
USA USA Mexico
ISO 13485/CMDCAS I.S.EN ISO13485:2012 ISO 9001:2015
MD19.4987
Single
Plymouth
MN
USA
I.S.EN ISO13485:2012
14.2967/A AS19.2967 AS19.2967/A 14.2967 AS19.4809
Secondary Primary Secondary Primary Single
Uxbridge Uxbridge Uxbridge Uxbridge Indianapolis
MA MA MA MA IN
USA USA USA USA USA
ISO 14001:2004 AS 9100 - C AS 9100 - C ISO 14001:2004 AS 9100 - C
19.4962
Single
Rome
GA
USA
ISO 9001:2008
MD19.8007 MD19.8007/C MD19.8007/A MD19.8007/B MD19.0301 19.3458
Secondary Primary Secondary Secondary Single Single
Amsterdam Dublin 18 Irvine Irvine Dublin 11 Cranston
CA CA RI
The Netherlands Ireland USA USA Ireland USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 ISO 9001:2008
ProComm Inc. of Hoopeston IL
19.4576
Primary
Onarga
IL
USA
ISO 9001:2015
ProComm designs and manufacturers communication accessories needed for Citizen Band, Amateur and Hi- Frequency Radio Systems. These accessories include (but are not limited to) antennas, cable assemblies, mounting systems and microphones
ProComm Inc. of Hoopeston IL
19.4576/A
Secondary
Onarga
IL
USA
ISO 9001:2015
ProComm designs and manufacturers communication accessories needed for Citizen Band, Amateur and Hi- Frequency Radio Systems. These accessories include (but are not limited to) antennas, cable assemblies, mounting systems and microphones
Prometheus DeltaTech
MD19.8042
Single
United Kingdom
I.S.EN ISO13485:2012
Proto Labs, Inc. Proto Labs, Inc. Proto Labs, Inc. Proxim Wireless Corporation PT. Excelitas Technologies Batam PT. Excelitas Technologies Batam PT. Excelitas Technologies Batam PT. Excelitas Technologies Batam PTC Corporation PTC Inc. PTC Inc. - Ann Arbor PTC Inc. - Blaine PTC Inc. - Fort Collins PTC Japan - Tokyo PTC Romania PTC software (India) Pvt. Ltd.
AS19.8015 19.4915 19.4914 19.3064 19.4455/A 14.4455/A 19.4455 14.4455 19.1192/O 19.1192 19.1192/J 19.1192/B 19.1192/M 19.1192/F 19.1192/Q 19.1192/I
Single Single Single Single Secondary Secondary Primary Primary Secondary Primary Secondary Secondary Secondary Secondary Secondary Secondary
USA USA USA USA Indonesia Indonesia Indonesia Indonesia Canada USA USA USA USA Japan Romania India
AS 9100 - C ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 9001:2015 ISO 14001:2004 ISO 9001:2015 ISO 14001:2004 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008
Purgo Biologics Inc.
MD19.8044/A
Secondary
Korea
I.S.EN ISO13485:2012
Purgo Biologics Inc.
MD19.8044/C
Secondary
Korea
I.S.EN ISO13485:2012
Purgo Biologics Inc.
MD19.8044/B
Secondary
Korea
I.S.EN ISO13485:2012
Purgo Biologics Inc.
MD19.8044
Primary
Korea
I.S.EN ISO13485:2012
14.4882
Primary
United Kingdom
ISO 14001:2004
PHOTONIS USA
Precision Engineering Inc. Precision Engineering Inc. Precision Engineering Inc. Precision Engineering Inc. Precision Rings Incorporated Premier Imaging/Medical Systems Inc. Presbia Co÷pertief U.A. Presbia PLC PresbiBio, LLC PresbiBio, LLC Pressco Ltd Primary Flow Signal, Inc.
Qioptiq Ltd
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Nashua Nashua Nashua Fremont
NH NH NH CA
Waterloo Needham Ann Arbor Blaine Fort Collins Tokyo BucharesT Pune
ON MA MI MN CO
Denbighshire
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The Design, Manufacture, and Distribution of Sterile, Single-Use Wound Dressings The forecasting, procurement, and distribution of pharmaceutical and in-vitro diagnostic products, and also secondary packaging of IVD products on behalf of third parties. The design, manufacturing, testing and sales of microchannel plates, electron multipliers, detectors and associated electronics for analytical instruments, ion guides, electron sources, fiber optic light guides and specialty glass products. The Design and Manufacture of Vacuum Electron Devices, Components and Systems. Manufacture and sales of custom and standard passive microelectronic components for the RF, Telecommunications, medical, military and commercial markets. 13485: The Manufacture and Distribution of Powered Nasal Cleaning Devices and Associated Sterile Saline Ampoules.9001: The Distribution of Private Label Baby Products Including, Pacifiers, Toys, and Sleeping Accessories. The Manufacture and Distribution of active medical devices used for cold compression therapies. The Design, Manufacture and Distribution of Hand Held Needle-Free Injection Devices for Drug Administration The manufacture of sealed lead acid batteries. The Design and Development, Manufacture, and Distribution of Implantable Tympanostomy Tube Systems and Related Delivery Devices. The fabrication and assembly of sheet metal components and assemblies, including welding and powdercoating. The fabrication and assembly of sheet metal components and assemblies, including welding and powdercoating. The fabrication and assembly of sheet metal components and assemblies, including welding and powdercoating. The fabrication and assembly of sheet metal components and assemblies, including welding and powdercoating. Design and Manufacture of Piston and Seal Rings On Site Assembler Of Imaging Devices And Installation of Biomedical Equipment; Asset Management, Technical Support and Service of Imaging and Biomedical Devices And Equipment. Design, Manufacture and Distribution of Intracorneal Lenses and Accessories Design, Manufacture and Distribution of Intracorneal Lenses and Accessories Design, Manufacture and Distribution of Intracorneal Lenses and Accessories Design, Manufacture and Distribution of Intracorneal Lenses and Accessories The contract manufacture, assembly and test of respiratory devices and electro mechanical assemblies. The design and manufacturing of flow measuring equipment.
The Design, Manufacture and Distribution of Emergency-Use Patient Stabilization Devices including Limb Splints, Traction Devices, Head Stabilization Devices and Wound Management Devices Prototype and Production of Machined and Assembled Parts. Low Volume Custom Cable and Wire Harness Manufactured to Customer Model Low Volume Sheet Metal Parts Manufactured to our Customers 3D Model The Design, Manufacturing and Marketing of Wireless Networking Products. Design and Manufacture of Optoelectronics Products. Manufacture of Optoelectronics Products. Design and Manufacture of Optoelectronics Products. Manufacture of Optoelectronics Products. The development and delivery of Technical Support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products. The development and delivery of technical support for PTC software products . The Design, Manufacture and Distribution of Natural Bone Substitute Materials, Non-resorbable PTFE Membranes, and Nonabsorbable PTFE Sutures. The Design, Manufacture and Distribution of Natural Bone Substitute Materials, Non-resorbable PTFE Membranes, and Nonabsorbable PTFE Sutures. The Design, Manufacture and Distribution of Natural Bone Substitute Materials, Non-resorbable PTFE Membranes, and Nonabsorbable PTFE Sutures. The Design, Manufacture and Distribution of Natural Bone Substitute Materials, Non-resorbable PTFE Membranes, and Nonabsorbable PTFE Sutures. Design, development and manufacture of visual and thermal imaging electro-optical components and subsystems, head up display optics, image intensified night vision sights, helicopter sights and holographic elements. The provision of associatedinservice support, tools and test equipment. The manufacture of space vehicle optical components.
01/18/18
Registration Number
Profile Type
CITY
Qioptiq Photonics GmbH & Co KG
19.4880/A
Primary
Qioptiq Photonics GmbH & Co KG Qioptiq Photonics GmbH & Co KG
19.4880/B 19.488
Qioptiq Photonics GmbH & Co. KG
COMPANY
Country
Scheme
D-85622 Feldkirchen
Germany
ISO 9001:2008
Secondary Secondary
D-94209 Regen D-37081 G÷ttingen
Germany Germany
ISO 9001:2008 ISO 9001:2008
19.4881
Single
D-35614 Asslar
Germany
ISO 9001:2008
Qioptiq Photonics GmbH & Co. KG
MD19.4883
Single
D-85622 Feldkirchen
Germany
I.S.EN ISO13485:2012
Qioptiq Photonics GmbH & Co.KG
18.4880/A
Single
Feldkirchen
Germany
BS OHSAS 18001:2007 Design, Manufacturing and Sales of Precision Optics, Optical-mechanical Systems and Optoelectronic Components.
Qioptiq Photonics Limited
19.4878
Single
Hamble, Hants
United Kingdom
ISO 9001:2008
Qioptiq Singapore Pte. Ltd.
19.4879
Single
Singapore
ISO 9001:2008
Qioptiq Singapore Pte. Ltd.
14.4879
Single
Singapore
ISO 14001:2004
Qioptiq Space Technology
AS19.4882/A
Secondary
Rhyl
United Kingdom
AS 9100 - C
Design, development and manufacture of visual and thermal imaging, electro optical components and sub-systems, head up display optics image intensified night vision sights, helicopter sights and holographic elements. The provision of associatedinservice support, tools and test equipment. The manufacture of space vehicle optical components.
Qioptiq Space Technology
14.4882/A
Secondary
Rhyl
United Kingdom
ISO 14001:2004
Design, development and manufacture of visual and thermal imaging electro-optical components and subsystems, head up display optics, image intensified night vision sights, helicopter sights and holographic elements. The provision of associatedinservice support, tools and test equipment. The manufacture of space vehicle optical components.
Qioptiq UK
AS19.4882
Primary
Denbighshire
United Kingdom
AS 9100 - C
Design, development and manufacture of visual and thermal imaging, electro optical components and sub-systems, head up display optics, image intensified night vision sights, helicopter sights and holographic elements. The provision of associatedinservice support, tools and test equipment. The manufacture of space vehicle optical components.
19.4744 AS19.4980/A AS19.4980
Single Secondary Primary
Northfield Santa Clarita Sylmar
NH CA CA
USA USA USA
ISO 9001:2008 AS 9100 - D AS 9100 - D
AS19.4958
Single
Sparks
NV
USA
AS 9100 - D
Randolph Products
19.4785
Single
Chicopee
MA
USA
ISO 9001:2008
Rapid DTM, Inc.
19.4675
Single
Amherst
NH
USA
ISO 9001:2008
RBC Medical Innovations
MD19.4482/A
Secondary
Lenexa
KS
USA
I.S.EN ISO13485:2012
RBC Medical Innovations
MD19.4482
Primary
Lenexa
KS
USA
I.S.EN ISO13485:2012
RCD Components, Inc. ReFlow Medical, Inc.
19.3094 MD19.4708
Single Single
Manchester San Clemente
NH CA
USA USA
ISO 9001:2008 I.S.EN ISO13485:2012
Remote Diagnostic Technologies Limited
MD19.8122
Single
Hampshire
United Kingdom
I.S.EN ISO13485:2012
Renchel Tool Inc
MD19.4357
Single
Putnam
USA
I.S.EN ISO13485:2012
Renew Health Limited
MD19.4975
Single
Co Westmeath
Ireland
I.S.EN ISO13485:2012
19.8094 19.489
Single Single
Austin Wilmington
TX MA
USA USA
ISO 9001:2015 ISO 9001:2015
Rimini Street Inc.
19.4623/A
Secondary
Las Vegas
NV
USA
ISO 9001:2008
Rimini Street Inc.
19.4623
Primary
Pleasanton
CA
USA
ISO 9001:2008
Rimini Street Inc.
19.4623/B
Secondary
Shinjuku-ku Tokyo
Japan
ISO 9001:2008
Rimini Street India Operations Pvt Ltd.
19.4623/D
Secondary
Bengaluru
India
ISO 9001:2008
Quality Controls, Inc. Quallion LLC Quallion LLC R.A.N. Performance, Inc.
RF Micron Rigaku Analytical Devices
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
CT
Karnataka
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope Design, Manufacturing, Distribution and Sales of Precision Optics, Optical Mechanical Systems and Optoelectronic Components. Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems. Design, Manufacturing and Sales of Precision Optics and Optical-Mechanical Systems. Development and Marketing of Precision Optical Products. Manufacturing of optical Components including Thin Film Surface Technology. Assembly and Test of opto-mechanical Devices and Systems Design, Manufacturing and Distribution of Dental Camera Systems, Precision Optics, Optical-Mechanical Systems and Optoelectronic Components.
The design, manufacture and sale of Fiber Optics, Lasers and Fiber Coupled Laser Systems for use in precision instrumentation. Design, Development, Production and Servicing of Advanced Military and Commercial Optical and Electro-Optics Components, Assemblies and Systems. Design, Development, Production and Servicing of Advanced Military and Commercial Optical and Electro-Optics Components, Assemblies and Systems.
Design, Manufacture and Distribution of Rotor Valves and Actuators. Design, Production and Distribution of Lithium Based Battery Systems and Raw Materials Design and Manufacturing of Lithium Based Battery Systems and Raw Materials for Lithium Ion Batteries Manufacture of precision components and assemblies for the aerospace, military, medical and commercial industries. Design and manufacture of coatings for the Department of Defense, OEM Industry, Wood Priming Market, Anti Slip Coatings Market and various other Specialty Industries. Provision of Manufacture, Inspection and Reverse Engineering Services for all Mold Types; Fixtures: Gauges: Prototype Parts and Secondary Castings, Based on Customer Requirements. The contract design, manufacture, and servicing of electro-mechanical assemblies and systems for the medical device industry. The contract design, manufacture, and servicing of electro-mechanical assemblies and systems for the medical device industry. The Design, Manufacture, Test and Supply of Active and Passive Electronic Components and Assemblies. The design, manufacture and distribution of endovascular guide catheters. Design, development and production of vital signs monitorsCMDCAS: Design and development, and manufacture of vital signs patient monitor (ECG, Blood 02, Blood Pressure, Respiration Rate, Temperature and Exhaled CO2) for diagnostic purposes9001: Design, development and prodcution of vital signs patient monitors. Contract Machining and Manufacturing of Components for the Medical Device Industry.ISO 9001 Scope: Contract CNC Machining. The manufacture and distribution of standard and custom fit ear canal inserts and kits for the treatment of Temporomandibular Joint Pain.The contract design, manufacturing and distribution of patient imaging and monitoring devices such as mobile ultrasound and distribution of external counter pulsation systems. Design, Distribution, and Support of Smart Passive Sensing Solutions Design, Development, Manufacture, and Support of Hardware and Software for Portable Scientific Instruments. Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates. Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates. Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates. Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Rimini Street India Operations Pvt. Ltd.
19.4623/C
Secondary
Hyderabad
Telangana
India
Royal Adhesives & Sealants, LLC
AS19.8125
Single
Ball Ground
GA
USA
SAFRAN Optics 1 SAFRAN Optics 1 Samsung Samsung Austin Semiconductor Samsung Austin Semiconductor Sauer Compressors USA
19.8041 19.8041/A 93.0046 14.48 18.48 19.4542
Primary Secondary Single Single Single Single
Bedford Arlington Austin Austin Austin Stevensville
NH VA TX TX TX MD
USA USA USA USA USA USA
SC Rompharm Company SRL
MD19.4974/C
Secondary
Romania
SC Rompharm Company SRL
MD19.4974
Primary
Romania
I.S.EN ISO13485:2012
SC Rompharm Company SRL
MD19.4974/A
Secondary
Romania
I.S.EN ISO13485:2012
SC Rompharm Company SRL
MD19.4974/B
Secondary
Ilfov, 075100
Romania
I.S.EN ISO13485:2012
SCA CHATEAU LA LAGUNE SchaererMedical USA, Inc.
14.4863 MD19.4668
Single Single
AQUITAINE Cincinnati
France USA
ISO 14001:2015 I.S.EN ISO13485:2012
Schivo
AS19.4979
Primary
Waterford
Ireland
AS 9100 - C
Schivo Medical
MD19.3983
Single
Waterford
Ireland
ISO 13485:2016
Schivo UK Ltd
AS19.4979/B
Secondary
Leicestershire LE19 2GA
United Kingdom
AS 9100 - C
MD19.4954
Single
Co. Kildare W91 KH68
Ireland
I.S.EN ISO13485:2012
19.4893
Single
San Diego
CA
USA
ISO 9001:2008
MD19.1388/3 MD19.1388HQ MD19.1388/4 MD19.1388/2
Secondary Primary Secondary Secondary
Superior Berkshire 3000 Leuven Stuttgart
CO
USA United Kingdom Belgium Germany
ISO 13485:2016 ISO 13485:2016 ISO 13485:2016 ISO 13485:2016
MD19.8048
Single
Carlsbad
CA
USA
I.S.EN ISO13485:2012
Selco Products
19.4775
Primary
Reno
NV
USA
ISO 9001:2015
Sensing Systems Corporation
19.4821
Single
New Bedford
MA
USA
ISO 9001:2015
Design and Manufacture a Full Range of Measurement Products and Provide Measurement Services to Various Industries The design and manufacture of remote power management technology for complex distributed computer networks. The design and development, manufacturing and distribution of sterile and non-sterile ultrasound probe covers; sterile procedure kits and gel-filled probe cover, and sterile and non-sterile ultrasound coupling gel. The design, manufacture and distribution of Topical containing plasmonic medical pigments for use as adjunct therapy in dermatologic laser procedures for hair removal, acne, skin resurfacing, treatment of pigmented lesions, cutaneous lesions, andother indicated dermatological applications. Design, Manufacturing and Distribution of Implantable Sutures The Design and Development, Manufacture, Distribution and Servicing of In-Vitro Diagnostic Systems including Hardware, Immunoassay Reagents, Calibrators and Controls. Contract Design and Development, Manufacturing and Distribution of Sterile and Non-Sterile Medical Devices. The manufacture of corrugated containers. The Information Security Management System at Zefone Ltd Trading as Smarttech Operating from Unit 11A, South Ring Business Park, Kinsale Road, Cork T12 W938 Ireland applies to the provision of Managed Security Services, Penetration Testing and ITSupport in accordance with Statement of Applicability û Version 3 dated 20 April 2016 Provider of Managed Security Services, Penetration Testing and IT Support The design and manufacture of precision tooling and replacement parts. The manufacture of precision components for the Medical Device IndustryISO9K Scope: The design and manufacture of precision tooling and replacement parts Design, Manufacture and Distribution of flexible plastic tubing for medical device applications. The Distribution of Active Surgical, Imaging, Monitoring, and Diagnostic Medical Equipment. The Refurbishment and Distribution of Active Surgical, Imaging, Monitoring, and Diagnostic Medical Equipment. Design, Manufacture, Distribution and Servicing of Endotracheal Tube Placement and Monitoring Systems
COMPANY
Schlotter Ireland DAC Scripps Laboratories SDL Flatiron SDL International SDL International Belgium NV SDL Multilingual Services GmbH & Co. KG SegWAY Orthopaedics, Inc
Server Technology, Inc.
OH
Co. Waterford
Scheme
Global provision of enterprise software support services, including client onboarding; client account management; product support for vendor delivered and client customized code; fix development and delivery; and research, development and delivery ofworldwide tax, legal and regulatory updates. Value added Packaging of Sealants and Adhesives to customer's specifications, servicing industries including, but not limited AS 9100 - D to Aerospace. Telecommunications, Rail Services, Automotive and Heavy Equipment ISO 9001:2008 Manufacture, Distribution and Service of Optronics Products, Solutions and Systems ISO 9001:2008 Manufacture, Distribution and Service of Optronics Products, Solutions and Systems ISO 50001 The energy activities and supporting processes associated with the design, fabrication, ISO 14001:2015 Wafer Fabrication and Testing BS OHSAS 18001:2007 Wafer Fabrication and Testing ISO 9001:2008 Design, Manufacture and support of high-pressure piston compressors for industrial, offshore and naval applications. The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate or Dextran Sulphate Sodium or Sodium Chrondroitin I.S.EN ISO13485:2012 Sulphate in prefilled syringes.The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate in vials.The Design, Manufacture and Distribution of Sterile Eye Drops in single-dose containers. ISO 9001:2008
19.3192
Single
Reno
NV
USA
ISO 9001:2015
MD19.3576/A
Single
Morgan Hill
CA
USA
ISO 13485/CMDCAS
Sienna Biopharmaceuticals, Inc.
MD19.4995
Single
Westlake Village
CA
USA
I.S.EN ISO13485:2012
Silhouette Lift, Inc.
MD19.4776
Single
Irvine
CA
USA
I.S.EN ISO13485:2012
Singulex, Inc.
MD19.4855
Single
Alameda
CA
USA
I.S.EN ISO13485:2012
Sirius Engineering LLC Sisco Corporation
MD19.8097 19.3551
Single Single
San Carlos Nashville
CA IL
USA USA
ISO 13485:2016 ISO 9001:2008
Smarttech
27.8027
Single
Cork
Ireland
ISO 27001:2013
Smarttech Smithstown Light Engineering
19.8027 14.063
Single Single
Cork Co. Clare
Ireland Ireland
ISO 9001:2015 ISO 14001:2004
Smithstown Light Engineering
MD19.1175
Single
Shannon
Co. Clare
Ireland
I.S.EN ISO13485:2012
Smooth-Bor Plastics
MD19.4560
Single
Laguna Hills
CA
USA
I.S.EN ISO13485:2012
Soma Technology, Inc.
MD19.4888
Single
Bloomfield
CT
USA
I.S.EN ISO13485:2012
SonarMed, Inc
MD19.4972
Single
Carmel
IN
USA
I.S.EN ISO13485:2012
Sheathing Technologies, Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope
The Design, Development, Manufacture and Distribution of Sterile Sodium Hyaluronate or Dextran Sulphate Sodium or Sodium Chrondroitin Sulphate in prefilled syringes.The Design, Development, Manufacture and Distribution of Sterile Sodium Hyaluronate in vials.The Design, Development, Manufacture and Distribution of Sterile Eye Drops in single-dose containers. The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate or Dextran Sulphate Sodium or Sodium Chrondroitin Sulphate in prefilled syringes.The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate in vials.The Design, Manufacture and Distribution of Sterile Eye Drops in single-dose containers. The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate or Dextran Sulphate Sodium or Sodium Chrondroitin Sulphate in prefilled syringes.The Design, Manufacture and Distribution of Sterile Sodium Hyaluronate in vials.The Design, Manufacture and Distribution of Sterile Eye Drops in single-dose containers. Vine Growing, AOC Wine Making, Packaging, Storage and Shipping The Design, Manufacture and Distribution of Surgical Tables. The Assembly, Precision Machining and Identification of Parts to Customer Specifications in Ferrous and Non-Ferrous Materials. The Manufacture, Assembly and Test of Precision Machined Parts and Electro-Mechanical Assemblies for the Medical Device Industry. The manufacture to customer drawings and specifications of light to medium precision machined components from ferrous and non-ferrous metals, using CNC and manually controlled machinery, including turning and milling. The Manufacture and Distribution of High Purity Chemicals for the Medical Device Industry. Process Development, Purification, and Sales of Enzymes, Proteins, Antibodies, and Related Bio-Chemicals for In-Vitro Clinical Diagnostic and Life Science Industries. The provision of translation and publishing services for the medical device industry. The provision of translation and publishing services for the medical device industry. The provision of translation and publishing services for the medical device industry. The provision of translation and publishing services for the medical device industry. The Design, Manufacture and Distribution of Sterile, Single-Use, Surgical Instruments for Use During Soft Tissue Release Procedures. The design, manufacture and marketing of electronic controls, sensors, thermal control devices, control knobs, heaters and related products.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
Sparton Beckwood
AS19.4580
Single
Plaistow
NH
USA
AS 9100 - C
Spinal Kinetics, Inc.
MD19.4986
Single
Sunnyvale
CA
USA
I.S.EN ISO13485:2012
Spiration, Inc.
MD19.4217
Single
Redmond
WA
USA
ISO 13485/CMDCAS
Sponge-Jet, Inc. Sponge-Jet, Inc.
19.4834 19.4834/A
Primary Secondary
Newington Montrose
NH PA
USA USA
ISO 9001:2015 ISO 9001:2015
SPSmedical Supply Corp, a subsidiary
MD19.4985
Primary
Rush
NY
USA
I.S.EN ISO13485:2012
SPSmedical Supply Corp, a subsidiary
MD19.4985/A
Secondary
Cuba
NY
USA
I.S.EN ISO13485:2012
Stamping Technologies, Inc. Standex de MΘxico S.A. de C.V.
19.4746 19.2317/A
Single Single
Laconia Nogales, Sonora
NH
USA Mexico
ISO 9001:2015 ISO 9001:2015
STENTYS S.A.
MD19.5249
Primary
Paris
France
I.S.EN ISO13485:2012
SteriPack USA (Limited) LLC
MD19.4730
Single
Lakeland
USA
ISO 13485:2003
Stratus Technologies
19.1068/A
Single
Dublin 15
Ireland
ISO 9001:2008
Stryker Manufacturing S. de R.L. de C.V
MD19.4140
Primary
Tijuana Baja California
Mexico
ISO 13485:2003
Stryker Manufacturing S. de R.L. de C.V
MD19.4140/A
Secondary
Tijuana Baja California
Mexico
ISO 13485:2003
MD19.4960 MD19.4902
Single Single
Woodinville Jacksonville
WA FL
USA USA
ISO 13485:2003 I.S.EN ISO13485:2012
19.2939
Single
Sterling
VA
USA
ISO 9001:2008
MD19.4868 MD19.4868/A
Primary Secondary
San Jose San Jose
CA CA
USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
MD19.5142
Single
VD
Switzerland
I.S.EN ISO13485:2012
19.8059
Primary
Addison
USA
ISO 9001:2008
Designs, implements, and manages advanced integrated logistic solutions from business solutions and base operations.
COMPANY
Summit Imaging, Inc. Sunlight Medical, Inc. Sutron Corporation Suture Ease, Inc. Suture Ease, Inc. Symetis SA syncreon
FL
IL
Scope Contract Manufacturer of Electro-Mechanical Assemblies for the Military, Aerospace, Semiconductor, Analytical Instrumentation and Automotive Markets. Design and Development, Manufacturing and Distribution of Orthopaedic Spinal Implants and Surgical Instruments for Orthopaedic Applications. Design, development, manufacture and distribution of bronchoscopic devices, delivery catheters, and related accessories for biopsy, lung volume reduction, and the treatment of damaged and/or diseased lung. The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface Preparation Equipment. The Design, Manufacture, Service, and Distribution of Abrasive Media and Surface Preparation Equipment. The design, manufacture and distribution of sterilization monitoring and assurance products including chemical indicators, chemical integrators, biological indicators, sterilization packaging and accessories for the healthcare industry, and theprovision of sterilizer monitoring services. The design, manufacture and distribution of sterilization monitoring and assurance products including chemical indicators, chemical integrators, biological indicators, sterilization packaging and accessories for the healthcare industry, and theprovision of sterilizer monitoring services. The Manufacture of Stamped, Cold Formed, Coined and CNC Machined Metal Parts. The Manufacture of Procon Pumps The design, manufacture and distribution of implantable bare-metal and drug-eluting cardiovascular stents and related delivery systems, embolectomy/thrombectomy catheters and dilation catheters.ISO9k:The design, manufacture and distribution of, implantable bare-metal and drug-eluting cardiovascular stents and related delivery systems, embolectomy/thrombectomy catheters and dilation catheters. The Manufacture and Distribution of Sterilizable Healthcare Packaging, Injection Molding, and the Contract Design, Assembly, Packaging, Sterilization and Testing of Medical Devices. The worldwide assembly, repair, test and logistics of critical on-line computers. The Contract Manufacture of Single-Use Medical Products Such as Gowns, Molded Products & Components Used in Medical Devices Industry. The Contract Manufacture of Single-Use Medical Products Such as Gowns, Molded Products & Components Used in Medical Devices Industry. The Provision of Service and Repair Activities for Ultrasound Medical Equipment and Digital X-ray Detector Plates. The Design, Manufacture and Distribution of Sterile Pipettes Used in IVF and Related Procedures. The design and manufacture of environmental monitoring and control systems, providing real-time data collection, telemetry, control and system software to forecast activities in the areas of hydrology,meterology and water management. Applications and services include: water supply, flood warning, irrigation control, maximizing hydro-power production, dam safety, tidal, groundwater and many others. The Design, Manufacture, and Distribution of Non-Active Laparoscopic Suturing Devices. The Design, Manufacture, and Distribution of Non-Active Laparoscopic Suturing Devices. The Design, Manufacture and Distribution of Percutaneous Tissue Heart Valve Prostheses and Related Delivery Catheters, Introducers and Surgical Instruments
syncreon
14.806
Primary
Ontario
Canada
ISO 14001:2015
Implements and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon
19.8059/B
Secondary
Ontario
Canada
ISO 9001:2008
Designs, implements, and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon
19.8059/C
Secondary
Torrance
CA
USA
ISO 9001:2008
Designs, implements, and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon
19.8059/D
Secondary
Olive Branch
MS
USA
ISO 9001:2008
Designs, implements, and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon
19.8059/F
Secondary
Fairburn
GA
USA
ISO 9001:2015
Implements and manages advanced integrated logistic solutions from business solutions and base operations.Site specific scope: Implements, and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon
14.8060/A
Secondary
Fairburn
GA
USA
ISO 14001:2015
Implements and manages advanced integrated logistic solutions from business solutions and base operations.
syncreon Duisburg
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
27.8031/B
Secondary
47059 Duisburg
Germany
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
ISO 27001:2013
The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
01/18/18
COMPANY
syncreon EMEAR HQ
syncreon Fairburn
syncreon Hinckley
Registration Number
27.8031
27.8031/D
27.8031/A
Profile Type
Primary
Secondary
Secondary
CITY
STATE
County Dublin
Fairburn
Ireland
GA
Hinckley, Leicestershire
syncreon Itasca
27.8031/E
Secondary
Ilasca
syncreon Mexico CJ
19.8059/E
Secondary
SyncroPhi Systems Ltd
MD19.3981
Syntech International Also dba
Country
USA
United Kingdom
ISO 27001:2013
ISO 27001:2013
ISO 27001:2013
USA
ISO 27001:2013
Cuidad Juarez
Mexico
ISO 9001:2008
Single
Co. Galway
Ireland
I.S.EN ISO13485:2012
MD19.4097
Single
Irvine
CA
USA
ISO 13485:2003
Synvasive Technology, Inc.
MD19.2757
Single
El Dorado Hills
CA
USA
I.S.EN ISO13485:2012
Synvasive Technology, Inc.
MD19.8057
Single
Reno
NV
USA
I.S.EN ISO13485:2012
19.4203 19.4324 14.4773
Single Single Single
Austin Boylston Stratford
TX MA CT
USA USA USA
ISO 9001:2015 ISO 9001:2008 ISO 14001:2004
T2 Biosystems Inc.
MD19.4876
Primary
Lexington
MA
USA
I.S.EN ISO13485:2012
T2 Biosystems Inc.
MD19.4876/A
Secondary
Wilmington
MA
USA
I.S.EN ISO13485:2012
T2 Biosystems Inc.
MD19.4876/D
Secondary
Lexington
MA
USA
I.S.EN ISO13485:2012
T2 Biosystems Inc.
MD19.4876/C
Secondary
Lexington
MA
USA
I.S.EN ISO13485:2012
19.1547
Single
Lincoln
RI
USA
ISO 9001:2015
AS19.8118/A
Secondary
Fredericktown
MO
USA
AS 9100 - D
Systems & Processes Engineering Corp. T.M. Electronics, Inc. T/C Distribution Company
Tanury Industries TBM Inc.,/Aviation Fluids Services
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
IL
Scheme
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
The ISMS applies to the assets and processes involved in syncreon’s provision of Distribution, Reverse Logistics, Supply Chain Management and Contract Manufacturing Services at syncreon Dublin EMEAR HQ, 1A Airport Business Park, Cloghran, Dublin County, Ireland, syncreon Hinckley, Unit 5, Logix Park, Watling Street, Hinckley, Leicestershire, LE10 3BQ, UK, syncreon Duisburg, Am Blumenkampshof 83, 47059 Duisburg, Germany, syncreon Niederaula, Am Friedrichsfeld 2, 36272 Niederaula, Germany, syncreon Fairburn, 1000 Logistics Center Drive, Suite 200 Fairburn, GA 30213, USA and software development at syncreon Itasca, 1075 Hawthorn Dr. Itasca, IL 60143 in accordance with the Statement of Applicability Version 5 1st March 2017.
Designs, implements, and manages advanced integrated logistic solutions from business solutions and base operations. The design, manufacture, distribution, installation & service of wireless ambulatory patient monitoring and clinical decision support system. The design and contract manufacture of sterile and non sterile, single and multi use medical and industrial products including but not limited to gowns, moulded and electro-mechanical products and components used in medical devices and industry The Design, Manufacture, and Distribution of Surgical Saw Blades. The Design, Manufacture, and Distribution of Balancing Systems and Prosthetic Implantation Instruments for Orthopaedic Surgery. Design, manufacture and service of electro-mechanical equipment used in defense and commercial applications. Design, Manufacture, Sales and Service of Leak, Flow and Seal Strength Test Instrumentation and Accessories. Food Distribution Warehouse Services The Design, Manufacture, Distribution and Service of In-Vitro Diagnostic Systems, including Hardware, Software, and Reagents, Controls and Panels for the Detection of Candida. The Design, Manufacture, Distribution and Service of In-Vitro Diagnostic Systems, including Hardware, Software, and Reagents, Controls and Panels for the Detection of Candida. The Design, Manufacture, Distribution and Service of In-Vitro Diagnostic Systems, including Hardware, Software, and Reagents, Controls and Panels for the Detection of Candida. The Design, Manufacture, Distribution and Service of In-Vitro Diagnostic Systems, including Hardware, Software, and Reagents, Controls and Panels for the Detection of Candida. The provision of electroplating and precious metal finishing services. Custom repackaging, manufacture and distribution of paints and coatings, hydraulic fluids, oils, chemicals, adhesives, sealants, saturated wipers, greases and related dispensing equipment and dispensing equipment replacement parts for the aerospace,space and defense industries
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
AS19.8118
Primary
Pevely
MO
USA
AS 9100 - D
TEK Microsystems, Inc.
19.4682
Single
Chelmsford
MA
USA
ISO 9001:2008
Teledyne Hanson Research
19.2623
Single
Chatsworth
CA
USA
ISO 9001:2015
Teledyne Judson Technologies
19.2831
Single
Montgomeryville
PA
USA
ISO 9001:2008
Teleflex Medical
MD19.1284
Single
Co. Limerick
Ireland
I.S.EN ISO13485:2012
The Design, Development and Manufacture under contract of Precision Extrusions, Composite Catheter Constructions, Components and minimally invasive Medical Devices for OEM Manufacturers.The Design, Development and Manufacture of Components for minimally invasive Medical Device Applications for OEM Manufacturers.
Teleplan International
14.2645/A
Secondary
Roseville
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on computer Peripheral Equipment and Information Technology Products.
Teleplan International
14.2645/B
Secondary
Lincoln
CA
USA
ISO 14001:2004
Provide Screening, Repair and Logistics Services on Computer Peripheral Equipment and Information Technology Products.
Teleplan International
18.2645
Primary
Roseville
CA
USA
Teleplan International
19.2645/B
Secondary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
19.2645/A
Secondary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
19.2645
Primary
Roseville
CA
USA
ISO 9001:2008
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
14.2645
Primary
Roseville
CA
USA
ISO 14001:2004
Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
18.2645/A
Secondary
Roseville
CA
USA
BS OHSAS 18001:2007 Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
18.2645/B
Secondary
Roseville
CA
USA
BS OHSAS 18001:2007 Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
Teleplan International
R214.2645/A
Secondary
Roseville
CA
USA
R2:2013
Provide Screen, Repair, Test and Recycling of Computer Peripheral Equipment and Information Technology Products.
Teleplan International
R214.2645
Primary
Roseville
CA
USA
R2:2013
Provide Screen, Repair, Test and Recycling of Computer Peripheral Equipment and Information Technology Products.
Teleplan International
R214.2645/B
Secondary
Roseville
CA
USA
R2:2013
Provide Screen, Repair, Test and Recycling of Computer Peripheral Equipment and Information Technology Products.
COMPANY TBM Inc.,/Aviation Fluids Services
Tennant Company
Custom repackaging, manufacture and distribution of paints and coatings, hydraulic fluids, oils, chemicals, adhesives, sealants, saturated wipers, greases and related dispensing equipment and dispensing equipment replacement parts for the aerospace,space and defense industries Designs, manufactures, delivers and services high performance signal acquisition, generation, processing and recording products for embedded real time computer systems, including integration of Tekmicro and third party products into turnkeyplatforms and systems. The design, manufacture, installation and service of laboratory equipment. The research, design, development, and manufacture of standard and custom high performance Infrared Detectors, Focal Plane Arrays (FPAÆs), and Integrated Dewar Cooler Assemblies (IDCAÆs) for the Commercial, Space and Defense Markets.
BS OHSAS 18001:2007 Provide screening, repair and logistics services on computer peripheral equipment and information technology products.
19.4477
Single
Minneapolis
MN
USA
ISO 9001:2015
Teradyne
19.4121/M
Secondary
San Jose
CA
USA
ISO 9001:2015
Teradyne (Asia) Pte. Ltd
19.4121/K
Secondary
Singapore
ISO 9001:2015
Teradyne ATE
19.4121/B
Secondary
Agoura Hills
CA
USA
ISO 9001:2015
Teradyne ATE
19.4121
Primary
North Reading
MA
USA
ISO 9001:2015
Teradyne ATE
19.4121/H
Secondary
Heredia
Costa Rica
ISO 9001:2015
Teradyne Ltd, Systems Test Group,
Scope
The Design, Manufacture, Sales & Service of Industrial Indoor & Outdoor Cleaning Equipment. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production.Site Specific Scope: Supply Chain Management Services and Pilot Line Assembly. Installation, service, sales and support of automated test equipment for the military/aerospace industries. The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Equipment from New Product Conception through Mature Production.
Test Test Test Test Test
19.4939
Single
Berkshire
United Kingdom
ISO 9001:2008
Teradyne Philippines Ltd.
19.4121/N
Single
6015 Cebu
Philippines
ISO 9001:2015
Teradyne STG
AS19.4318
Single
North Reading
USA
AS 9100 - C
Teradyne Suzhou
19.4121/J
Secondary
Suzhou, Jiangsu
China
ISO 9001:2015
The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
Teradyne, Inc.
14.4118
Single
North Reading
MA
USA
ISO 14001:2015
All Environmental Activities Associated with Process Design, Assembly, Repair and Servicing of Test Equipment from New Product Conception through Mature Production at the Premises located at 600 Riverpark Dr., North Reading MA
Teradyne, Inc.
19.4121/L
Secondary
Buffalo Grove
IL
USA
ISO 9001:2015
The Process Design, Manufacturing process development and monitoring, Installation and Servicing Support of Automatic Test Equipment from New Product Conception through Mature Production.
The Carlyle Johnson Machine Co., LLC
AS19.4425
Single
Bolton
CT
USA
AS 9100 - C
The Henry Perkins Company The Seaberg Company, Inc.
19.4766 MD19.4360
Single Single
Bridgewater Wilsonville
MA OR
USA USA
ISO 9001:2008 I.S.EN ISO13485:2012
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
MA
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Test
Manufacturer of In-Circuit and Functional Automated Test Equipment for Commercial, Military, and Aerospace Industries.
The Design and Manufacture of Electromagnetic, Mechanical, Air and Hydraulic Clutches and Brakes, and Related Devices. The Manufacture of Gray, Ductile and Wear-resistant Iron Castings. The Design, Manufacture and Distribution of Orthopaedic Appliances, Supplies and Wound Care Devices.
01/18/18
Registration Number
Profile Type
CITY
STATE
Country
Scheme
19.4602
Single
Grand Forks
ND
USA
ISO 9001:2008
Theradome Inc.
MD19.4999
Single
Pleasanton
CA
USA
I.S.EN ISO13485:2012
Thermedx LLC
COMPANY The UND Aerospace Foundation
MD19.4553
Single
Solon
OH
USA
ISO 13485/CMDCAS
Thermo Scientific Portable Analytical
19.4735
Single
Tewksbury
MA
USA
ISO 9001:2008
Thermoplastic Comfort System, Inc.
MD19.8020
Single
Signal Hill
CA
USA
I.S.EN ISO13485:2012
Thompson MIS LLC
MD19.4992
Single
Londonderry
NH
USA
I.S.EN ISO13485:2012
Thorlabs Quantum Electronics
19.4769
Single
Jessup
MD
USA
ISO 9001:2008
Tool and Plastic Company Ltd Torden Consumer Products
MD19.4356 19.812
Single Single
Phoenix
Berks AZ
Ireland USA
I.S.EN ISO13485:2016 ISO 9001:2015
14.0156/4
Single
Pinellas Park
FL
USA
ISO 14001:2004
14.0196 19.1237 MD19.1237 MD19.4226
Single Single Single Single
Co. Westmeath Co. Westmeath Co. Westmeath Portland
OR
Ireland Ireland Ireland USA
ISO 14001:2004 ISO 9001:2015 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
Trimble AB
19.4967/N
Secondary
Danderyd
Sweden
ISO 9001:2015
Trimble Electronic Products (Shanghai)
19.4967/Q
Single
Shanghai, 200131
China
ISO 9001:2015
Trimble Europe BV
19.4967/E
Secondary
5521DZ Eersel
Netherlands
ISO 9001:2015
Trimble Inc.
19.4967/A
Secondary
Sunnyvale
CA
USA
ISO 9001:2015
Trimble Inc.
19.4967/B
Secondary
Dayton
OH
USA
ISO 9001:2015
Trimble Inc.
19.4967/C
Secondary
Corvallis
OR
USA
ISO 9001:2015
Trimble Inc.
19.4967
Primary
Sunnyvale
CA
USA
ISO 9001:2015
Trimble Inc.
19.4967/H
Secondary
Tempe
AZ
USA
ISO 9001:2015
Trimble Inc.
19.4967/J
Secondary
Derby DE24 8GX
United Kingdom
ISO 9001:2015
Trimble Inc.
19.4967/K
Secondary
Ipswich IP2 8SD
United Kingdom
ISO 9001:2015
Trimble Inc.
19.4967/M
Secondary
Chennai - 600113
India
ISO 9001:2015
Trimble Inc.
19.4967/P
Single
Auckland
New Zealand
ISO 9001:2015
TriVascular, Inc.
MD19.4556
Single
Santa Rosa
CA
USA
I.S.EN ISO13485:2012
19.3571
Single
Wheeling
WV
USA
ISO 9001:2008
Trulife
MD19.0958
Single
Dublin 24
Ireland
I.S.EN ISO13485:2012
Turner Medical Inc.
MD19.4658
Single
Athens
AL
USA
ISO 13485:2003
Twelve, Inc.
MD19.8134
Single
Redwood City
CA
USA
ISO 13485:2003
Typenex Medical LLC
MD19.4412
Single
Chicago
IL
USA
I.S.EN ISO13485:2012
U-Media Communications, Inc.
TL19.4617/A
Secondary
Hu-kou, Hsin-Chu
Taiwan
TL9000 R6.0/R5.0
Transitions Optical, Inc. Trend Technologies Mullingar Ltd. Trend Technologies Mullingar Ltd. Trend Technologies Mullingar Ltd. Tricol Biomedical, Inc.
TROY Group, Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope Developing and conducting training programs, research and development, custom software development and consulting services related to the aerospace industry. The Design, Manufacture and Distribution of Low-Level Laser Therapy Devices for Hair Growth The design, manufacture and distribution of active warming systems for infusion and irrigation and related accessories. Design, Manufacture and Distribution of Portable Analytical Instruments The manufacture and distribution of dental resins, dental equipment and dental accessories for use in dental laboratories for the fabrication of removable dental appliances. The Design and Development, Manufacture, Distribution, and Servicing of Orthopaedic and Neurologic Implants and Instruments. Design, develop, manufacture, and repair of laser diodes, electro-optic modulators, patterned optics and integrated photonics modules and subsystems for the photonics market. Manufacture and assembly of plastic components for the medical device and healthcare sector. The Manufacture and Distribution of E liquid for use in E-cigarettes The design and development of photochromic technology and the photochromic treatment of lenses for the global opthalmic market. The manufacture and assembly of precisiom plastic injection mouldings. The manufacture and assembly of precisiom plastic injection mouldings. The manufacture of injection moulded components and sub-assemblies for the medical device industry. The Design, Manufacture and Distribution of Hemorrhage Control Wound Management Devices. Design, provide service programs for and manufacture advanced optical instruments used in the surveying and construction markets. Manufacturing of Optical and Laser Instruments for Engineering Positioning and Surveying Distribution of Navigation and Machine Control Components, Devices and Systems that Provide Positioning, Timing, Tracking, Location and Navigation Information for use in Construction, Agriculture, Mapping, Survey, Automotive, Aviation and AerospaceIndustries. Design, Manufacture, Sales, Servicing and Distribution of Navigation and Machine Control Components, Devices and Systems that Provide Positioning, Timing, Tracking, Location and Navigation Information for use in Construction, Agriculutre, Mapping,Survey, Automotive, Aviation and Aerospace Industries. Design, Manufacture, Sales, Servicing and Distribution of Navigation and Machine Control Components, Devices and Systems that Provide Positioning, Tracking, Location, Leveling, Alignment, Grade Control and Navigation Information for use inConstruction, Agriculture, Mapping, Survey, and Mobile Asset Industries. Design of Products that Deliver Positioning and/or Timing Information to Customers for Various Tracking, Location, Timing and Navigation Applications Associated with Construction, Agriculture, Mapping, Survey, Automotive, Military, Aviation,Aerospace and Mobile Asset Industries. Such products include, but are not limited to: Devices Capable of Data Collection, Storage, and Cell Phones. Design, Manufacture, Sales, Servicing and Distribution of Navigation and Machine Control Components, Devices and Systems that Provide Positioning, Timing, Tracking, Location and Navigation Information for use in Construction, Agriculture, Mapping,Survey, Automotive, Aviation and Aerospace Industries. Servicing of Field Service Products that Deliver Positioning and/or Timing Information to Customers for Various Tracking, Location, Timing and Navigation Applications Associated with the Mobile Asset Industries. Servicing of Field Service Products that Deliver Positioning and/or Timining Information to Customers for Various Tracking, Location, Timing and Navigation Applications Associated with the Mobile Asset Industries. Design of Field Service Products that Deliver Positioning and/or Timing Information to Customers for Various Tracking, Location, Timing and Navigation Applications Associated with the Mobile Asset Industries. Design and Servicing of Field Service Products that Deliver Positioning and/or Timing Information to Customers for Various Tracking, Location, Timing and Navigation Applications Associated with the Mobile Asset Industries. Design , Manufacture and Supply of Specialized Custom Industrial Electronics The design, manufacture and distribution of implantable devices for the treatment of descending thoracic aneurysm, abdominal aortic aneurysm and related delivery devices and accessories. The design, development, manufacture, service and technical support of MICR and specialty printing supplies, printer solutions and the qualification and manufacturing of secure digital printing systems The design, manufacture, distribution and customer support of breast prostheses, pressure relieving and positioning products and operating room theatre supports. The distribution of medical theatre/hospital equipment, walking & orthopaedic aids andaccessories. The service of hospital equipment including patient treatment trollies, stirrups, heat-sealers & warming cabinets. The contract manufacture and supply of components and assemblies used in the medical industry Design, development, manufacturing, including sterilization, and distribution of a cardiac valve implant and associated accessories. The Design, Manufacture and Distribution of Blood Sampling and Dispensing Accessories for Use During In-Vitro Diagnostic Testing. TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/ Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for the following service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of Wireless Access Point (AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server
01/18/18
Registration Number
Profile Type
CITY
U-Media Communications, Inc.
TL19.4617
Primary
Hsinchu City
UltraLinq Healthcare Solutions
MD19.8087
Primary
New York
UltraLinq Healthcare Solutions
MD19.8087/A
Secondary
Durham
19.4813
Single
19.3544 19.4133 19.4012 19.401 19.4148 19.4521 19.4541
Single Single Single Single Single Single Single
Unisys Corporation
19.4239
Unisys Corporation
COMPANY
Country
Scheme
Taiwan
TL9000 R6.0/R5.0
NY
USA
I.S.EN ISO13485:2012
NC
USA
I.S.EN ISO13485:2012
Panama City Beach
FL
USA
ISO 9001:2008
Design, Fabrication and Testing of Military Systems, Ocean Submersibles, Remote Operated Vehicles and Related Equipment
Texarkana Edgefield Beaver Milan Yazoo City Littleton EL RENO
TX SC WV MI MS CO OK
USA USA USA USA USA USA USA
ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2008 ISO 9001:2015 ISO 9001:2015 ISO 9001:2008
Single
Irvine
CA
USA
ISO 9001:2015
14.0097
Single
Irvine
CA
USA
ISO 14001:2015
The production of air conditioning filters. Manufacture of textile clothing/products. Manufacture and assembly of office furniture. Manufacture and assembly of office furniture. Manufacture of Textile Clothing/Products The Manufacture of Clothing/Textile Products Sheet metal fabrication Suppy Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop Ship and Logistics Activities for Unisys Enterprise-class Server Products and Services. Supply Chain Operation that Provides Order Fulfillment, Mechanical Assembly and Test, Drop ship and Logistics Activities for Unisys Enterprise-class Server Products and Services.
United Drug
19.5145
Single
Co Mayo
Ireland
ISO 9001:2008
The wholesaling and distribution of pharmaceutical products, medical device products and distribution of consumer products.
United Drug Supply Chain Services
19.208
Single
Dublin 24
Ireland
ISO 9001:2008
The distribution of pharmaceuticals, consumer products, cosmetic, photographic and medical equipment. The processing of ostomy bags. The secondary packaging activities of pharmaceutical and consumer goods.
Urotronic Inc
MD19.8085
Single
Minneapolis
MN
USA
I.S.EN ISO13485:2012
The Design, Manufacture and Distribution of Drug Coated Urinary Dilation Catheters for the Treatment of Urinary Symptoms.
US Endodontics
MD19.4830
Single
Johnson City
TN
USA
I.S.EN ISO13485:2012
Valeant Amsterdam Logistics Center
MD19.3178
Single
Netherlands
I.S.EN ISO13485:2012
MD19.4443/B
Secondary
Sollentuna, 19138
Sweden
ISO 13485/CMDCAS
MD19.4487
Single
San Jose
CA
USA
I.S.EN ISO13485:2012
19.8022 19.4555
Single Single
Miami Rochester
FL NY
USA USA
ISO 9001:2015 ISO 9001:2008
MD19.4478
Primary
Santa Clara
CA
USA
I.S.EN ISO13485:2012
Varex Imaging Deutschland AG
MD19.4478/A
Secondary
Walluf
Germany
I.S.EN ISO13485:2012
Vasorum Ltd. Velco Tool & Die, Inc Velco Tool & Die, Inc
MD19.5077 MD19.4588 MD19.4588/A
Single Secondary Primary
Lake Forest Lake Forest
Dublin 24 CA CA
Ireland USA USA
I.S.EN ISO13485:2012 I.S.EN ISO13485:2012 I.S.EN ISO13485:2012
Velocity Electronics Corp
14.4774
Single
Austin
TX
USA
ISO 14001:2004
Velocity Electronics Corp
18.4774
Single
Austin
TX
USA
OHSAS 18001:2007
Ventec Life Systems
MD19.8045
Single
Bothell
WA
USA
I.S.EN ISO13485:2012
Veryan Medical Ltd
MD19.5072
Single
Co Galway
Ireland
Wallac Oy
MD19.4443
Primary
Turku
Finland
18.4443
Single
Turku
Finland
UNDERSEA SOLUTIONS GROUP UNICOR Federal Prison Industries, UNICOR Federal Prison Industries, UNICOR Federal Prison Industries, UNICOR Federal Prison Industries, UNICOR Federal Prison Industries, UNICOR Federal Prison Industries, UNICOR Federal Prison Industries,
Inc. Inc. Inc. Inc. Inc. Inc. Inc.
Vanadis Diagnostics
Vander-Bend Manufacturing Vapor Shark VarData LLC Varex Imaging
Wallac Oy, PerkinElmer Oy Wallac Oy, PerkinElmer Oy Waterford Intellectual Disability Waterford Intellectual Disability Waterford Intellectual Disability Waterford Intellectual Disability ** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
STATE
14.4443
Single
Turku
Finland
19.5059/1 19.5059/2 19.5059/3 19.5059/4
Secondary Secondary Secondary Secondary
Waterford Co Waterford Waterford Waterford
Ireland Ireland Ireland Ireland Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
Scope TL 9000-H Scope: Design and Manufacture of Wireless Access Point (AP)/ Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server Product for the following service category: 6.2.4 Digital Data Service Units.QMS Scope: Design and Manufacture of Wireless Access Point (AP)/Router/Bridge/Adaptor, Digital Multimedia Adaptor/Player/Server. The Design, Manufacture, and Distribution of Imaging and Data Management System Software, which are Intended to Receive, Process, Review, Display and Archive Medical Images and Data The Design, Manufacture, and Distribution of Imaging and Data Management System Software, which are Intended to Receive, Process, Review, Display and Archive Medical Images and Data
CMDCAS Scope: The Design, Manufacture and Distribution of Endodontic Obturators, Verifiers and Dental Rotary Files.MD Scope: The Manufacture and Distribution of Endodontic Obturators, Verifiers and Dental Rotary Files. The logistics and distribution of contact lenses, contact lens care products, and surgical products. The management of postponement and repackaging activities for contact lenses and lens care products. The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic instruments and software used in the diagnosis and monitoring of cancer, fertility, endocrine disorders and in the management of maternalhealth screening, neonatal screening, prenatal screening and as an aid in diagnosis. ISO 9001 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including Cable Harnesses.ISO 13485 Scope: Contract Manufacture of Precision Sheet Metal Products, Precision Machined Components, Electromechanical Assemblies including Cable Harnesses integrated into Medical Devices. Design, Manufacture and Distribution of e-liquid Electronic Cigarette Solutions Reseller of technology for voice, data and storage networks for both enterprise and service providers. The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging Applications in the Hospital/Clinical Setting. The Design, Manufacture, Distribution and Service of Panels and Detectors for X-Ray Imaging Applications in the Hospital/Clinical Setting. The design, manufacture and distribution of minimally invasive, non-active devices for closure of vascular punctures Manufacture of plastic and metal components for the medical device industry. Manufacture of plastic and metal components for the medical device industry. The inspection, storage, and distribution of electronic components and related products and the performance of supply chain solutions. The inspection, storage, and distribution of electronic components and related products and the performance of supply chain solutions. The design and development, manufacture and service of an integrated respiratory system and related accessories providing mechanical ventilation, oxygen, cough, suction and nebulizer therapies for use in hospital, home and transport applications.
The design, development and manufacture of non-active, implantable and non-implantable, peripheral and coronary vascular devices and related delivery systems. The design and manufacture of in-vitro diagnostic test kits, in-vitro diagnostic reagents, in-vitro diagnostic instruments and ISO 13485/CMDCAS software used in the diagnosis and monitoring of cancer, fertility, endocrine disorders and in the management of maternalhealth screening, neonatal screening, prenatal screening and as an aid in diagnosis. Research, product development, production, domestic sales and service, and technical support of instruments, reagents and BS OHSAS 18001:2007 software in the business areas of analytical and diagnostic systems. Research, product development, production, dosmestics sales and service, and technical support of instruments, reagents and ISO 14001:2015 software in the business areas of analytical and diagnostic systems. ISO 9001:2008 The provision of intellectual disability services, including residential care, respite care and day services ISO 9001:2008 The provision of intellectual disability services, including residential care, respite care and day services ISO 9001:2008 The provision of intellectual disability services, including residential care, respite care and day services ISO 9001:2008 The provision of intellectual disability services, including residential care, respite care and day services I.S.EN ISO13485:2012
01/18/18
Waterford Intellectual Disability Waterford Intellectual Disability
19.5059 19.5059/5
Profile Type Primary Secondary
WaterSep BioSeparations Corp.
19.8073
Single
Marlborough
MA
USA
ISO 9001:2015
Wenco Molding Inc WestFab Manufacturing WestRock-Puerto Rico, Inc.
19.4949 19.362 19.3503
Single Single Single
Providence Santa Clara Guaynabo
RI CA PR
USA USA Puerto Rico
ISO 9001:2008 ISO 9001:2015 ISO 9001:2008
Whitman Products
19.4265
Single
North Andover
MA
USA
ISO 9001:2008
MD19.4466 MD19.4466/B 19.2864/B MD19.1114 MD19.4923 19.4848
Primary Secondary Single Single Single Single
Riviera Beach Delray Beach Albuquerque Co. Cork Sandy Meredith
FL FL NM UT NH
USA USA USA Ireland USA USA
ISO 13485/CMDCAS ISO 13485/CMDCAS ISO 9001:2015 I.S.EN ISO13485:2012 ISO 13485:2003 ISO 9001:2008
Xandex, Inc
19.2463/B
Secondary
Petaluma
CA
USA
ISO 9001:2008
Xandex, Inc
19.2463/A
Secondary
Petaluma
CA
USA
ISO 9001:2008
Xandex, Inc.
19.2463
Primary
Petaluma
CA
USA
ISO 9001:2008
Xcaper Industries, LLC
19.4669
Single
Irvine
CA
USA
ISO 9001:2008
Xcerra Corporation
19.4578
Primary
Norwood
MA
USA
ISO 9001:2008
Xcerra Corporation
19.4578/A
Secondary
Milpitas
CA
USA
ISO 9001:2008
Xeridiem Medical Devices
MD19.2170
Single
Tucson
AZ
USA
I.S.EN ISO13485:2012
Ximedica, LLC
MD19.4422
Single
Providence
RI
USA
I.S.EN ISO13485:2012
Ximedica, LLC
MD19.4422/A
Secondary
Plymouth
MN
USA
I.S.EN ISO13485:2012
19.4525
Single
Vienna
VA
USA
ISO 9001:2008
COMPANY
Registration Number
CITY
Country
Scheme
Scope
Ireland Ireland
ISO 9001:2008 ISO 9001:2008
19.4391
Single
Hudson
MA
USA
ISO 9001:2008
The provision of intellectual disability services, including residential care, respite care and day services. The provision of intellectual disability services, including residential care, respite care and day services The Development, Manufacture, Distribution, and Post Distribution Customer Support of Filters for Discovery, Scale-Up, and Cross-Flow Process Applications across Various Industries. Manufacturing of Plastic Injection Molded Components. Manufacture of Precision Sheet Metal, Machining and Assemblies The design and manufacture of corrugated containers. Contract manufacturer of Electronic Assemblies, servicing the Instrumentation Commercial, Military, Telecommunications, RF, Medical, Industrial and Automotive Industries. Manufacture and Distribution of Sterile Saline for Topical Use. Manufacture and Distribution of Sterile Saline for Topical Use. The distribution, sales, and testing of Quartz glassware for the semiconductor fabrication industry. The manufacture and packaging of sterile orthopedic implants and related instrumentation. Contract Machining of Orthopedic Implants Manufacture of Ferrous and Non-Ferrous, Plastic and Polyurethane Products. The Design, Development and Manufacture of Test and Assembly Equipment for the Semiconductor Industry and Products for the Renewable Energy Industry. The Design, Development and Manufacture of Test and Assembly Equipment for the Semiconductor Industry and Products for the Renewable Energy Industry. The Design, Development and Manufacture of Test and Assembly Equipment for the Semiconductor Industry and Products for the Renewable Energy Industry. The Design and Manufacture of Moist Direct Contact Filter and Mask for Smoke, Gas Protection, Particulate Matter and Vapors from Smoke. The design, development, manufacture, installation and service support of linear, digital, mixed signal and discrete semiconductor test equipment and associated applications in North America, Europe and Asia. The design, development, manufacture, installation and service support of linear, digital, mixed signal and discrete semiconductor test equipment and associated applications in the North America, Europe and Asia. The Design and Development, Manufacture, and Distribution of Packaged Sterile and Bulk Non-Sterile Catheters, Tubing and Tubing Sets, Drainage Devices, and Stoma Devices for Cardiovascular, Peripheral, Urological, and Enteral Feeding Applications,Surgical Instruments and Cardiac Leads. The provision of product design, engineering and contract manufacturing services for medical device customers. Assembly and packaging of electro-mechanical capital medical devices and assembly, packaging of sterile/non-sterile medical disposables. The provision of product design, engineering and contract manufacturing services for medical device customers. Assembly and packaging of electro-mechanical capital medical devices and assembly, packaging of sterile/non-sterile medical disposables. Corporate management processes for employee time keeping, payroll and invoicing relating to the supply of program management, engineering and technical and international mission-support services. Manufacturer and supplier of plastic extruded components to the commercial and medical device industries.
YSI, Inc.
MD19.4705/A
Secondary
Yellow Springs
OH
USA
I.S.EN ISO13485:2012
The design, manufacture and service of glucose and lactate monitoring instruments and reagents used in medical applications.
YSI, Inc.
MD19.4705
Primary
Yellow Springs
OH
USA
I.S.EN ISO13485:2012
The design, manufacture and service of glucose and lactate monitoring instruments and reagents used in medical applications.
19.1496
Single
Laureldale
PA
USA
ISO 9001:2015
Winchester Laboratories, LLLP Winchester Laboratories, LLLP WONIK Quartz International Corporation Wright X-1 Precision, Inc. Xact Tech Inc.
XL Associates, Inc Xponent Global, Inc.
Yuasa Battery, Inc.
Waterford Waterford
STATE
Zehnacker Ireland Healthcare
MD19.5562/HQ
Primary
Co. Kildare
Ireland
I.S.EN ISO13485:2012
Zehnacker Ireland Healthcare Zehnacker Ireland Healthcare Zehnacker Ireland Healthcare
19.5562/3 19.5562HQ 19.5562/1
Secondary Primary Secondary
Co Waterford Co Kildare Dublin 11
Ireland Ireland Ireland
ISO 9001:2008 ISO 9001:2008 ISO 9001:2008
Zehnacker Ireland Healthcare
MD19.5562/1
Secondary
Dublin 11
Ireland
I.S.EN ISO13485:2012
Zevas Communications Ltd
27.8028
Single
Cork
ZIEHL-ABEGG, Inc.
19.4597
Single
Greensboro
MD19.8098
Single
Plymouth
Zurich Medical Inc.
** To confirm the validity of certifications, suspended or withdrawn, please contact NSAI at 603-882-4412
Ireland
ISO 27001:2013
NC
USA
ISO 9001:2008
MN
USA
I.S.EN ISO13485:2012
Single - Individual Certification Primary - Multisite Headquaters Secondary - Multisite Facility
The design, manufacture and distribution of lead acid batteries and accessories. MD Scope: The Provision of Decontamination and Sterilization Services for Reusable Medical Devices.ISO9K Scope: The Provision of decontamination and sterilization services, and facility cleaning and catering services. The Provision of decontamination and sterilization services, and facility cleaning and catering services. The Provision of decontamination and sterilization services, and facility cleaning and catering services. The Provision of decontamination and sterilization services, and facility cleaning and catering services. MD Scope: The Provision of Decontamination and Sterilization Services for Reusable Medical Devices.ISO9K Scope: The Provision of decontamination and sterilization services, and facility cleaning and catering services. The operation of an Information Security Management System relating to the provision of Call Centre service, in the form of inbound and outbound telecommunication, web chat and emails, data handling and administration at Unit 8, Cleve Business Park,Monahan Road, Cork, Ireland. Statement of Applicability Version 3 dated 11 May 2016 with the following exclusions: A.8.3.1- No removable media is permitted. A.9.4.4- No utility programs that can override systems and application controls are used.A.14.1.3- Zevas do not process service transactions. A.14.2.7- Zevas do not outsource development Fabrication, Assembly, Service and Distribution of Axial and Centrifugal Fans and External Rotor Motors The Design, Manufacture, and Distribution of Active Guidewire Systems and Related Accessories for Cardiac and Peripheral Pressure Gradient Monitoring
01/18/18
