Identity
- Trade Name
- SOFT CARE EUDAMED
- Model / Reference
- HEAD COVER TISSUE EUDAMED109.201.W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05208107004012 EUDAMED
- Basic UDI-DI
- 5208107109201S6 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - 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 | 5208107109201S6 | Class I | Active |
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Manufacturer
- Manufacturer
- Bournas Medicals
- EUDAMED SRN
- GR-MF-000023099
Sources (1)
- EUDAMED 15b63753-c38f-4333-9050-eca1d8acc46c 61 fields · synced Jun 18, 2026