Certification body registry profile

SGS Fimko Oy

SGS Fimko Oy is listed in the Certiget registry as a certification body with the recorded country or location Finland. The profile includes confirmed data for Directive 93/42/EEC, ISO 13485:2016, ISO 14001:2015, together with available accreditation, technical-sector and location information.

Certiget1 accreditation relationshipsFinland

Key facts

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

Accreditation relationships

SGS Fimko OyAccreditation body — name unavailable in canonical8 standards

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

Certification standards (8)

Directive 93/42/EECISO 13485:2016ISO 14001:2015ISO 45001:2018ISO 9001:2015ISO/IEC 27001:2022ISO/IEC 3834-2:2021 and SFS-EN ISO 9001Regulation 2017/745/EU

Technical sectors (50)

1.1

Non-Active Medical Devices

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

Active Medical Devices (Non-Implantable)

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

1.4

In Vitro Diagnostic Medical Devices (IVD)

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

1.4.B

In Vitro Diagnostic Instruments and software

1.4.C

IVD medical devices other than specified above

1.5

Sterilization Method for Medical Devices

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

Devices Incorporating / Utilizing Specific Substances / Technologies

1.6.A

Medical devices incorporating medicinal substances

1.6.B

Medical devices utilizing tissues of animal origin

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

Parts or Services

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

14

Rubber and plastic products

17

Basic metals and fabricated metal products

18

Machinery and equipment

19

Electrical and optical equipment

25

Electricity supply

29

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

31

Transport, storage and communication

33

Information technology

34

Engineering services

Locations (3)

Corporate Head Office

Takomotie 8, Helsinki, 00380, Finland

Head Office

Särkiniementie, Helsinki, Finland

Head Office

Särkiniementie 3, Helsinki, 00211, Finland

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