Identity
- Trade Name
- PREMA Compact EUDAMED
- Device Name
- PREMA Mattress range EUDAMED
- Model / Reference
- PREMA Mattress range EUDAMEDHC00104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09344090002003 EUDAMED
- Basic UDI-DI
- 942904017343PREMA44 EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
PREMA Compact by Howard Wright Limited — 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 | 942904017343PREMA44 | Class I | Active |
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Manufacturer
- Manufacturer
- Howard Wright Limited
- EUDAMED SRN
- NZ-MF-000009802
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 8a993dee-41ca-47b3-8043-13418f09ae17 61 fields · synced Jul 23, 2026