Certification body registry profile

GMED

GMED is listed in the Certiget registry as a certification body with the recorded country or location France. The profile includes confirmed data for ISO 13485:2016, ISO 9001:2015, NF EN ISO 13485/A11:2021, together with available accreditation, technical-sector and location information.

Certiget1 accreditation relationshipsFrance

Key facts

Country / location
France
Accreditation relationships
1
Confirmed standards
3
Locations
8
Data stewardship
Certiget

Accreditation relationships

GMEDAccreditation body — name unavailable in canonical3 standards

The accreditation holder identity has not been confirmed. Only the preserved relationship is shown.

Certification standards (3)

ISO 13485:2016ISO 9001:2015NF EN ISO 13485/A11:2021

Technical sectors (53)

1.1

Non-Active Medical Devices

Full

1.1.A

General non-active, non-implantable medical devices

Full

1.1.B

Non-active implants

Full

1.1.C

Devices for wound care

Full

1.1.D

Non-active dental devices and accessories

Full

1.1.E

Non-active medical devices other than specified above

Full

1.2

Active Medical Devices (Non-Implantable)

Full

1.2.A

General active medical devices

Full

1.2.B

Devices for imaging

Full

1.2.C

Monitoring devices

Full

1.2.D

Devices for radiation therapy and thermo therapy

Full

1.2.E

Active (non-implantable) medical devices other than specified above

Full

1.3

Active Implantable Medical Devices

Full

1.3.A

General active implantable medical devices

Full

1.3.B

Implantable medical devices other than specified above

Full

1.4

In Vitro Diagnostic Medical Devices (IVD)

Full

1.4.A

Reagents and reagent products, calibrators and control materials for: Clinical Chemistry Immunochemistry (Immunology) Haematology/Haemostasis/Immunohematology Microbiology Infectious Immunology Histology/Cytology Genetic Testing

Full

1.4.B

In Vitro Diagnostic Instruments and software

Full

1.4.C

IVD medical devices other than specified above

Full

1.5

Sterilization Method for Medical Devices

Full

1.5.A

Ethylene oxide gas sterilization (EOG)

Full

1.5.B

Moist heat

Full

1.5.C

Aseptic processing

Full

1.5.D

Radiation sterilization (e.g. gamma, x-ray, electron beam)

Full

1.5.E

Low temperature steam and formaldehyde sterilization

Full

1.5.F

Thermic sterilization with dry heat

Full

1.5.G

Sterilization with hydrogen peroxide

Full

1.5.H

Sterilization method other than specified above

Full

1.6

Devices Incorporating / Utilizing Specific Substances / Technologies

Full

1.6.A

Medical devices incorporating medicinal substances

Full

1.6.B

Medical devices utilizing tissues of animal origin

Full

1.6.C

Medical devices incorporating derivates of human blood

Full

1.6.D

Medical devices utilizing micromechanics

Full

1.6.E

Medical devices utilizing nanomaterials

Full

1.6.F

Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed

Full

1.6.G

Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.

Full

1.7

Parts or Services

Full

1.7.A

Raw materials

Full

1.7.B

Components

Full

1.7.C

Subassemblies

Full

1.7.D

Calibration services

Full

1.7.E

Distribution services

Full

1.7.F

Maintenance services

Full

1.7.G

Transportation services

Full

1.7.H

Other services

Full

13

Pharmaceuticals

Full

14

Rubber and plastic products

Full

19

Electrical and optical equipment

Full

23

Manufacturing not elsewhere classified

Full

29

Wholesale and retail trade; Repair of motor vehicles, motorcycles and personal and household goods

Full

33

Information technology

Full

38

Health and social work

Full

4

Textiles and textile products

Full

Locations (8)

Regional Head Office

2600 Tower Oaks Blvd Suite 500, ROCKVILLE, MD 20852, United States of America (the)

Regional Head Office

1 rue Gaston Boissier, PARIS, 75015, France

Corporate Head Office

1 rue Gaston Boissier, PARIS, 75015, France

Regional Head Office

19 RUE DE LA TELEMATIQUE, SAINT ETIENNE, 42000, France

Site

1 rue Gaston Boissier, PARIS, 75015, France

Site

19 D rue de la Télématique, SAINT ETIENNE, 42000, France

Head Office

1 rue Gaston Boissier, PARIS cedex 15, 75724, France

Site

6550 Rock Spring Driven suite 280, BETHESDA MD, 20817, United States of America (the)

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