Procedo International Certification s.r.o.

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

1.6

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.E

Medical devices utilizing nanomaterials

1.6.F

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

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

Corporate Head Office

Ulica Svornosti 42, Bratislava, 821 06, Slovakia