Identity
- Trade Name
- Alerta Gel-Visco Cushion EUDAMED
- Device Name
- Alerta Gel Cushion EUDAMED
- Model / Reference
- ALT-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614530558 EUDAMED
- Basic UDI-DI
- 506061453GelCushionZ6 EUDAMED
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS 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 Gel-Visco 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 | 506061453GelCushionZ6 | 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 7b690ff2-7e8d-4973-9246-e1f71b653d40 61 fields · synced Jun 19, 2026