Identity
- Trade Name
- Soft Care EUDAMED
- Device Name
- Hygiene Series EUDAMED
- Model / Reference
- Hygiene Series EUDAMED108.015.SAM150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05208107011232 EUDAMED
- Basic UDI-DI
- 5208107106108109Z2 EUDAMED
- EMDN Code
- T030502 BED AND STRETCHER HYGIENIC COVERS 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 | 5208107106108109Z2 | Class I | Active |
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Manufacturer
- Manufacturer
- Bournas Medicals
- EUDAMED SRN
- GR-MF-000023099
Sources (1)
- EUDAMED 326e59ef-d542-4829-8ebf-d29e48c6dd1b 61 fields · synced Jun 18, 2026