Identity
- Trade Name
- Viola II 20x20 EUDAMED
- Device Name
- Viola II EUDAMED
- Model / Reference
- Viola Series EUDAMEDUPRA2020-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056019101158 EUDAMED
- Basic UDI-DI
- 50560191VOI001C8 EUDAMED
- EMDN Code
- V08030101 ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Viola II 20x20 by Ultimate Healthcare — Class IIa — 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 | 50560191VOI001C8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ultimate Healthcare
- EUDAMED SRN
- GB-MF-000021288
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED b8a7ee5b-d414-46e2-86a9-ac972e84ab1b 61 fields · synced Jun 19, 2026