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Distalock Humerus Locking Screw Ø3.5×32 mm
EUDAMEDClass IIb (EU MDR)
Ref 243-035-032Model Humerus Nail Locking Screw
Identity
- Trade Name
- Distalock Humerus Locking Screw Ø3.5×32 mm EUDAMED
- Device Name
- Distalock Humerus Locking Screw Ø3.5×32 mm EUDAMED
- Model / Reference
- Humerus Nail Locking Screw EUDAMED243-035-032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682704635690 EUDAMED
- Basic UDI-DI
- B-08682704635690 EUDAMED
- EMDN Code
- P09120604 OSTEOSYNTHESIS NAIL-SCREW SYSTEMS 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 Humerus Locking Screw Ø3.5×32 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-08682704635690 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Otta Tibbi̇ Ci̇hazlar Ve Medi̇kal A.ş.
- EUDAMED SRN
- TR-MF-000022268
Sources (1)
- EUDAMED e2f7176d-2ec5-498a-9c94-9b4551efa7c6 61 fields · synced Jul 27, 2026