Identity
- Trade Name
- GEL OVATIONS EUROPE EUDAMED
- Device Name
- 312G EUDAMED
- Model / Reference
- 214G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060937941987 EUDAMED
- Basic UDI-DI
- 506093794312G2P 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 | 506093794312G2P | 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 cde735e6-15fe-4f6a-8200-17bffaea8879 61 fields · synced Jun 19, 2026