Identity
- Trade Name
- Alerta Patient Foam Wedge, Large (sloped) EUDAMED
- Device Name
- Alerta Sensaflex 200 Foam Cushion EUDAMED
- Model / Reference
- ALT-PW-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614531371 EUDAMED
- Basic UDI-DI
- 506061453FoamCushionKR EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I 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
Alerta Patient Foam Wedge, Large (sloped) by Alerta Medical Ltd — 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 | 506061453FoamCushionKR | Class I | Active |
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Manufacturer
- Manufacturer
- Alerta Medical Ltd
- EUDAMED SRN
- GB-MF-000013708
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 8ea512eb-2c1d-4baf-81d8-829aa8f97355 61 fields · synced Jun 19, 2026