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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass III (EU MDR)
Ref E.70539-01002
Identity
- Trade Name
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- TOTAL KNEE PROSTHESIS TIBIAL INSERT (P/S) HYPERFLEX 55 / 11 mm (UHMWPE) EUDAMED
- Model / Reference
- E.70539-01002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-86809415270209U EUDAMED
- Basic UDI-DI
- B-86809415270209U 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
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — 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-86809415270209U | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016470
Sources (1)
- EUDAMED 31ca5d1d-0948-416c-9966-a8d096d4ea94 61 fields · synced Oct 6, 2026