Identity
- Trade Name
- SOFIA NOIRE EUDAMED
- Device Name
- SOFIA EUDAMED
- Model / Reference
- 1020064S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615800000364 EUDAMED
- Basic UDI-DI
- 361580SOFIACD EUDAMED
- Direct Marketing DI
- 03615800000364 EUDAMED
- EMDN Code
- Y12030601 ELBOW CRUTCHES 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
Sofia Noire 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 | 361580SOFIACD | Class I | Active |
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Manufacturer
- Manufacturer
- Vilgo
- EUDAMED SRN
- FR-MF-000009712
Sources (1)
- EUDAMED 8163b4de-a8b0-437c-bf75-2782e662e40d 61 fields · synced Jun 18, 2026