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Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
EUDAMEDClass IIb (EU MDR)
Ref E.4522-0931
Identity
- Trade Name
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ EUDAMED
- Device Name
- INTRAMEDULLARY COMPRESSION NAIL (ICN) TIBIA Ø9X315 mm (TI) EUDAMED
- Model / Reference
- E.4522-0931 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8680941254438A8 EUDAMED
- Basic UDI-DI
- B-8680941254438A8 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
Zi̇med Medi̇kal Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ by Zimed Medikal Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED
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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-8680941254438A8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
- EUDAMED SRN
- TR-MF-000015401
Sources (1)
- EUDAMED d841f3de-0d50-4cba-a83e-74b3bc0c5405 61 fields · synced Jun 18, 2026