Identity
- Trade Name
- Single-axis foot adapter EUDAMED
- Device Name
- Modular pieces for prosthetic leg EUDAMED
- Model / Reference
- GLE10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760260043 EUDAMED
- Basic UDI-DI
- 594476026ELTABCG00001EF EUDAMED
- Direct Marketing DI
- 05944760260043 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
Single-axis foot adapter by Elitex Prodexim 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 | 594476026ELTABCG00001EF | Class I | Active |
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Manufacturer
- Manufacturer
- Elitex Prodexim SRL
- EUDAMED SRN
- RO-MF-000033014
Sources (1)
- EUDAMED 79cfe040-d1a2-4805-8de0-527bd8b1edd6 61 fields · synced Jul 30, 2026