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Distalock Tibial End Cap 5mm Extension
EUDAMEDClass IIb (EU MDR)
Ref 120-000-005Model Tibia End Cap
Identity
- Trade Name
- Distalock Tibial End Cap 5mm Extension EUDAMED
- Device Name
- Distalock Tibial End Cap 5mm Extension EUDAMED
- Model / Reference
- Tibia End Cap EUDAMED120-000-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704631531 EUDAMED
- Basic UDI-DI
- B-08682704631531 EUDAMED
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Distalock Tibial End Cap 5mm Extension by Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08682704631531 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 4cd0dc45-7690-4cc2-8bd9-407c1741ff3c 61 fields · synced Jul 27, 2026