Identity
- Trade Name
- GEL OVATIONS EUROPE EUDAMED
- Device Name
- GEL FILLED CUSHION EUDAMED
- Model / Reference
- 14SFP0404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060937940645 EUDAMED
- Basic UDI-DI
- 506093794DIMJA EUDAMED
- EMDN Code
- Y122499 WHEELCHAIRS ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Gel Ovations Europe by Gel Ovations Europe Limited — 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 | 506093794DIMJA | Class I | Active |
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Manufacturer
- Manufacturer
- Gel Ovations Europe Limited
- EUDAMED SRN
- GB-MF-000024690
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED aa005943-bb87-46a5-b92c-9f9cdad9785b 61 fields · synced Jun 18, 2026