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Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass III (EU MDR)
Ref E.7539-0504
Identity
- Trade Name
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- TOTAL KNEE PROSTHESES TIBIAL INSERT (P/S) HYPERFLEX 75/15 MM (UHMWPE) EUDAMED
- Model / Reference
- E.7539-0504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680941259006AA EUDAMED
- Basic UDI-DI
- B-8680941259006AA EUDAMED
- EMDN Code
- P0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS EUDAMED
Classification
- Device Class
- Class III 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 III — 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-8680941259006AA | Class III | Active |
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Manufacturer
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
- EUDAMED SRN
- TR-MF-000015401
Sources (1)
- EUDAMED 35ddec9e-54c0-472e-9c8f-19f01eaac5ca 61 fields · synced Jun 18, 2026