Identity
- Trade Name
- Sedens 500 SE EUDAMED
- Device Name
- Dual Mode Pressure Relieving Seat Cushion EUDAMED
- Model / Reference
- 9P-048020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893356434 EUDAMED
- Basic UDI-DI
- 302500pcushionI01AP EUDAMED
- EMDN Code
- V08030101 ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS 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
Sedens 500 SE 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 | 302500pcushionI01AP | 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 1a15bb20-2af6-4b8f-8de4-3c283bd16bb3 61 fields · synced Jun 14, 2026