Identity
- Device Name
- Titanium Alloy Wrist Plates EUDAMED
- Model / Reference
- 04.426.751 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00196449018987 EUDAMED
- Basic UDI-DI
- 01964490085C EUDAMED
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Titanium Alloy Wrist Plates by Tyber Medical — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01964490085C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tyber Medical
- EUDAMED SRN
- US-MF-000011350
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED f9adb602-8e6e-4ab7-bd6a-7f63114340b2 61 fields · synced Jul 8, 2026