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Distalock Tibia Nail Ø11×360 mm
EUDAMEDClass IIb (EU MDR)
Ref 100-110-360Model Tibia Intramedullary Nail
Identity
- Trade Name
- Distalock Tibia Nail Ø11×360 mm EUDAMED
- Device Name
- Distalock Tibia Nail Ø11×360 mm EUDAMED
- Model / Reference
- Tibia Intramedullary Nail EUDAMED100-110-360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704631319 EUDAMED
- Basic UDI-DI
- B-08682704631319 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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
Category: Arthrodesis intramedullary nail, non-distracting
Distalock Tibia Nail Ø11×360 mm by Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08682704631319 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 66cfaa33-1ae8-47f5-93df-fff6431afc87 61 fields · synced Jul 30, 2026