HTCert - GFI Health Technology CertificationLimited

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.H

Sterilization method 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

13

Pharmaceuticals

19

Electrical and optical equipment

23

Manufacturing not elsewhere classified

29

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

31

Transport, storage and communication

33

Information technology

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