Identity
- Trade Name
- Articulatie de genunchi fix Al EUDAMED
- Device Name
- [EN]Knee joint fixed AL / [RO] Articulatie de genunchi fix Al EUDAMED
- Model / Reference
- OB51C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05949096398170 EUDAMED
- Basic UDI-DI
- 5949096398ELPROBWZ EUDAMED
- Direct Marketing DI
- 05949096398170 EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) 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
Category: Mechatronic external knee prosthesis
Articulatie de genunchi fix Al by Sc Elitex Prothetic Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechatronic external knee prosthesis.
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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 732e608a-6068-440f-a1dc-6d64029f95ae 61 fields · synced Jul 29, 2026