Identity
- Trade Name
- Offset tube clamp adapter EUDAMED
- Device Name
- Modular pieces for prosthetic leg EUDAMED
- Model / Reference
- B13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760260401 EUDAMED
- Basic UDI-DI
- 594476026ELTABCG00001EF EUDAMED
- Direct Marketing DI
- 05944760260401 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
Offset tube clamp adapter 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 | 594476026ELTABCG00001EF | Class I | Active |
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Manufacturer
- Manufacturer
- Elitex Prodexim SRL
- EUDAMED SRN
- RO-MF-000033014
Sources (1)
- EUDAMED e46111fb-52a8-4c22-8068-3a7610ac93f2 61 fields · synced Jun 19, 2026