Certification body registry profile

Intertek Medical Notified Body AB

Intertek Medical Notified Body AB is listed in the Certiget registry as a certification body with the recorded country or location Sweden. The profile includes confirmed data for ISO 13485:2016, SS-EN ISO 13485:2016, together with available accreditation, technical-sector and location information.

Certiget1 accreditation relationshipsSweden

Key facts

Country / location
Sweden
Accreditation relationships
1
Confirmed standards
2
Locations
1
Data stewardship
Certiget

Accreditation relationships

Intertek Medical Notified Body ABAccreditation body — name unavailable in canonical2 standards

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

Certification standards (2)

ISO 13485:2016SS-EN ISO 13485:2016

Technical sectors (33)

1.1.A

General non-active, non-implantable medical devices

1.1.B

Non-active implants

1.1.C

Devices for wound care

1.1.D

Non-active dental devices and accessories

1.1.E

Non-active medical devices other than specified above

1.2.A

General active medical devices

1.2.B

Devices for imaging

1.2.C

Monitoring devices

1.2.D

Devices for radiation therapy and thermo therapy

1.2.E

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

1.5.A

Ethylene oxide gas sterilization (EOG)

1.5.B

Moist heat

1.5.C

Aseptic processing

1.5.D

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

1.5.E

Low temperature steam and formaldehyde sterilization

1.5.F

Thermic sterilization with dry heat

1.5.G

Sterilization with hydrogen peroxide

1.5.H

Sterilization method other than specified above

1.6.A

Medical devices incorporating medicinal substances

1.6.B

Medical devices utilizing tissues of animal origin

1.6.C

Medical devices incorporating derivates of human blood

1.6.D

Medical devices utilizing micromechanics

1.6.E

Medical devices utilizing nanomaterials

1.6.F

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

1.6.G

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

1.7.A

Raw materials

1.7.B

Components

1.7.C

Subassemblies

1.7.D

Calibration services

1.7.E

Distribution services

1.7.F

Maintenance services

1.7.G

Transportation services

1.7.H

Other services

Locations (1)

-

Box 1103, Kista, 164 22, Sweden

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