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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref R.70072-05003
Identity
- Trade Name
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- REVISION KNEE PROSTHESIS FEMUR POSTERIOR CONDYLE WEDGE 5 mm SIZE 3 (TI) EUDAMED
- Model / Reference
- R.70072-05003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680941562946C4 EUDAMED
- Basic UDI-DI
- B-8680941562946C4 EUDAMED
- EMDN Code
- P09098099 KNEE PROSTHESES - ACCESSORIES - OTHER 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
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — 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-8680941562946C4 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016470
Sources (1)
- EUDAMED 97232eb3-cd6b-4ece-9d1f-934d6ae9d2fd 61 fields · synced Oct 6, 2026