Identity
- Trade Name
- Laba - picior protetic fix EUDAMED
- Device Name
- [EN]Knee joint fixed AL / [RO] Articulatie de genunchi fix Al EUDAMED
- Model / Reference
- OB10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05949096398217 EUDAMED
- Basic UDI-DI
- 5949096398ELPROBWZ EUDAMED
- Direct Marketing DI
- 05949096398217 EUDAMED
- EMDN Code
- Y062403 FOOT PARTIAL PROSTHESES (INCLUDING TOE PROSTHESES) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Laba - picior protetic fix by Sc Elitex Prothetic Srl — Class I — 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 | 5949096398ELPROBWZ | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Elitex Prothetic Srl
- EUDAMED SRN
- RO-MF-000042662
Sources (1)
- EUDAMED ee787135-0779-4342-965f-d697782c1d9d 61 fields · synced Jun 19, 2026