Certification body registry profile

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS) is listed in the Certiget registry as a certification body with the recorded country or location Spain. The profile includes confirmed data for ISO 13485, together with available accreditation, technical-sector and location information.

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Key facts

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

Accreditation relationships

AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)Accreditation body — name unavailable in canonical1 standards

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

Certification standards (1)

ISO 13485

Technical sectors (35)

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.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.A

General active implantable medical devices

Full

1.3.B

Implantable medical devices other than specified above

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

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.H

Sterilization method other than specified above

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

1.7.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

35

Other services

Full

Locations (1)

Branch Office

C/ Campezo, 1. Edificio 8, Madrid, 28022, Spain

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