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Lamination anchor with adjustment core for transfemoral socket
EUDAMEDClass I (EU MDR)
Ref A11
Identity
- Trade Name
- Lamination anchor with adjustment core for transfemoral socket EUDAMED
- Device Name
- Modular pieces for prosthetic leg EUDAMED
- Model / Reference
- A11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760260111 EUDAMED
- Basic UDI-DI
- 594476026ELTABCG00001EF EUDAMED
- Direct Marketing DI
- 05944760260111 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
Lamination anchor with adjustment core for transfemoral socket 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 83bcf105-1de9-4840-bb49-04b288d50226 61 fields · synced Oct 1, 2026