Certification body registry profile

UDEM ULUSLARARASI BELGELENDİRME DENETİM EĞİTİM MERKEZİ SANAYİ ve TİCARET ANONİM ŞİRKETİ

UDEM ULUSLARARASI BELGELENDİRME DENETİM EĞİTİM MERKEZİ SANAYİ ve TİCARET ANONİM ŞİRKETİ is listed in the Certiget registry as a certification body with the recorded country or location Türkiye. The profile includes confirmed data for ISO/IEC 17021: 2011, TS EN ISO 13485:2016, TS EN ISO/IEC 17021-1:2015, together with available accreditation, technical-sector and location information.

Certiget1 accreditation relationshipsTürkiye

Key facts

Country / location
Türkiye
Accreditation relationships
1
Confirmed standards
3
Locations
2
Data stewardship
Certiget

Accreditation relationships

UDEM ULUSLARARASI BELGELENDİRME DENETİM EĞİTİM MERKEZİ SANAYİ ve TİCARET ANONİM ŞİRKETİAccreditation body — name unavailable in canonical3 standards

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

Certification standards (3)

ISO/IEC 17021: 2011TS EN ISO 13485:2016TS EN ISO/IEC 17021-1:2015

Technical sectors (34)

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

1.5

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.F

Thermic sterilization with dry heat

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.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

Locations (2)

Corporate Head Office

MUTLUKENT MAH. 2073 SK. No:10/ ÇANKAYA/ANKARA, Ankara, Türkiye

Head Office

Mutlukent Mahallesi 2073 Sokak No:10 Ümitköy, ANKARA, 6810, Türkiye

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