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Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref E.40302-13280
Identity
- Trade Name
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- CANNULATED INTRAMEDULLARY RETROGRADE FEMORAL NAIL 13 X 280 mm (Ti) EUDAMED
- Model / Reference
- E.40302-13280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-868094152107397 EUDAMED
- Basic UDI-DI
- B-868094152107397 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
Category: Arthrodesis intramedullary nail, non-distracting
Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Gold Ortopedi̇ Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class IIb — MDD — listed in EUDAMED
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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-868094152107397 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016470
Sources (1)
- EUDAMED cfbc1f63-eee6-45fa-b1ba-45156ebdf890 61 fields · synced Oct 5, 2026