Identity
- Trade Name
- Alerta Sensaflex 300 Foam Cushion EUDAMED
- Device Name
- Alerta Sensaflex 200 Foam Cushion EUDAMED
- Model / Reference
- ALT-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614530473 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 Sensaflex 300 Foam Cushion 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alerta Medical Ltd
- EUDAMED SRN
- GB-MF-000013708
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 52a4676e-388f-4965-b4d6-4acc54a11418 61 fields · synced Jun 19, 2026