Identity
- Trade Name
- OMEGA NOIR EUDAMEDOMEGA NOIR DECOR EUDAMED
- Device Name
- OMEGA EUDAMED
- Model / Reference
- 1050015S12 EUDAMED1050015S11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615800013722 EUDAMED03615800013715 EUDAMED
- Basic UDI-DI
- 361580OMEGAA8 EUDAMED
- Direct Marketing DI
- 03615800013722 EUDAMED03615800013715 EUDAMED
- EMDN Code
- Y120603 WALKING FRAMES, 4 TIPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Omega Noir by Vilgo — 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 | 361580OMEGAA8 | Class I | Active |
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Manufacturer
- Manufacturer
- Vilgo
- EUDAMED SRN
- FR-MF-000009712
Sources (2)
- EUDAMED e4f10dc1-024e-45fe-ae38-ca335dd925b6 61 fields · synced Jul 30, 2026
- EUDAMED dc68a4de-2edc-4c90-9d79-4b127b769ad8 61 fields · synced May 17, 2026