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Distalock Tibia Nail Ø9×300 mm
EUDAMEDClass IIb (EU MDR)
Ref 100-090-300Model Tibia Intramedullary Nail
Identity
- Trade Name
- Distalock Tibia Nail Ø9×300 mm EUDAMED
- Device Name
- Distalock Tibia Nail Ø9×300 mm EUDAMED
- Model / Reference
- Tibia Intramedullary Nail EUDAMED100-090-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704631036 EUDAMED
- Basic UDI-DI
- B-08682704631036 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
Distalock Tibia Nail Ø9×300 mm 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-08682704631036 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED 075dbb08-9115-4c5f-a06f-4e7f963837c4 61 fields · synced Jul 29, 2026