Identity
- Trade Name
- Orthotic knee joint with lock for children EUDAMED
- Device Name
- Orthoses EUDAMED
- Model / Reference
- S3K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760260388 EUDAMED
- Basic UDI-DI
- 594476026ELTS00000001WP EUDAMED
- Direct Marketing DI
- 05944760260388 EUDAMED
- EMDN Code
- Y06121201 PASSIVE KNEE-ANKLE-FOOT ORTHOSES 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
Orthotic knee joint with lock for children 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 | 594476026ELTS00000001WP | Class I | Active |
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Manufacturer
- Manufacturer
- Elitex Prodexim SRL
- EUDAMED SRN
- RO-MF-000033014
Sources (1)
- EUDAMED 2cc2bb45-b349-468e-88d8-b8a903df5f78 61 fields · synced Jun 18, 2026