Identity
- Trade Name
- Solid ankle foot EUDAMED
- Device Name
- Prosthetic feet EUDAMED
- Model / Reference
- LF-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760260234 EUDAMED
- Basic UDI-DI
- 594476026ELTLFM000001M4 EUDAMED
- Direct Marketing DI
- 05944760260234 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
Solid ankle foot by Elitex Prodexim 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 | 594476026ELTLFM000001M4 | Class I | Active |
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Manufacturer
- Manufacturer
- Elitex Prodexim SRL
- EUDAMED SRN
- RO-MF-000033014
Sources (1)
- EUDAMED 50a072f1-9b3b-436d-96b0-5bf6cd42a1de 61 fields · synced Jul 8, 2026