Identity
- Trade Name
- SOFT CARE EUDAMED
- Model / Reference
- MEDICAL MASKS EUDAMED121.011.PU.IIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05208107006924 EUDAMED
- Basic UDI-DI
- 5208107121010QT EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Soft Care by Bournas Medicals — 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 | 5208107121010QT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bournas Medicals
- EUDAMED SRN
- GR-MF-000023099
Sources (1)
- EUDAMED dbd8eeec-128e-4713-8f22-2068a1e35886 61 fields · synced Jun 19, 2026