Identity
- Trade Name
- Adaptor cu piramida - gamba EUDAMED
- Device Name
- [EN]Knee joint fixed AL / [RO] Articulatie de genunchi fix Al EUDAMED
- Model / Reference
- OB30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05949096398231 EUDAMED
- Basic UDI-DI
- 5949096398ELPROBWZ EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER 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
Adaptor cu piramida - gamba 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 c863ea8b-8d7c-423c-aa78-07dcb10bbb63 61 fields · synced Jul 19, 2026