Identity
- Trade Name
- Crossover Air Mattress EUDAMED
- Device Name
- Alternating Pressure Redistribution System EUDAMED
- Model / Reference
- 9M052001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893356212 EUDAMED
- Basic UDI-DI
- 302500pmattressI019B EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Crossover Air Mattress by Wellell Inc. — 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 | 302500pmattressI019B | Class I | Active |
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Manufacturer
- Manufacturer
- Wellell Inc.
- EUDAMED SRN
- TW-MF-000009159
- Authorised Representative
- Wellell Iberia S.L. ES-AR-000003668
Sources (1)
- EUDAMED 1647eaf1-ff67-4f44-9d28-40bf620a8399 61 fields · synced Jul 10, 2026