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10711501246
EUDAMEDClass III (EU MDR)
Ref 10711501246Model A. UNIPOLAR HEAD S.S. 46 MM 12-14
Identity
- Model / Reference
- A. UNIPOLAR HEAD S.S. 46 MM 12-14 EUDAMED10711501246 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698673437593 EUDAMED
- Basic UDI-DI
- B-08698673437593 EUDAMED
- EMDN Code
- P090804050102 METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Metallic femoral head prosthesis
10711501246 by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Metallic femoral head prosthesis.
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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-08698673437593 | Class III | Active |
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Manufacturer
- Manufacturer
- Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇.
- EUDAMED SRN
- TR-MF-000017767
Sources (1)
- EUDAMED 881f2b71-3d52-4bc6-af2c-38725da0cd95 61 fields · synced Oct 9, 2026