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Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref 7853-1005
Identity
- Trade Name
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- TOTAL KNEE PROSTHESIS FEMORAL COMPONENT (C/R)CEMENTLESS-POROUS-COATED 75 mm RIGHT (CoCr) EUDAMED
- Model / Reference
- 7853-1005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8699131684993GP EUDAMED
- Basic UDI-DI
- B-8699131684993GP EUDAMED
- EMDN Code
- P0909030102 BICOMPARTMENTAL PRIMARY IMPLANT UNCEMENTED FEMORAL COMPONENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Zimed Medikal Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-8699131684993GP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
- EUDAMED SRN
- TR-MF-000015401
Sources (1)
- EUDAMED e6626003-39a8-4937-821c-4f45e1f4b798 61 fields · synced Oct 8, 2026