Identity
- Trade Name
- SOFFIA EUDAMED
- Device Name
- Matelas CARSOFT 4, SOFFIA, UNIMAT, ROTAMAT, HALFA, BARIA FORM EUDAMED
- Model / Reference
- MLAYM EUDAMED17.HMS602-10PU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664897032055 EUDAMED
- Basic UDI-DI
- 366489702658JN EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Soffia by Winncare France — 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 | 366489702658JN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Winncare France
- EUDAMED SRN
- FR-MF-000000482
Sources (1)
- EUDAMED 1fe75a49-5559-4350-844c-b942551ac8ef 61 fields · synced Jul 30, 2026