Identity
- Trade Name
- Procare Prone G2 EUDAMED
- Device Name
- Alternating Pressure Redistribution System EUDAMED
- Model / Reference
- 9P-087450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893357073 EUDAMED
- Basic UDI-DI
- 302500pmattressI019B EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Procare Prone G2 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 0564ea88-7472-4c6b-8d53-20e71099c463 61 fields · synced Jun 18, 2026