Identity
- Trade Name
- Alerta GelCube Cushion EUDAMED
- Device Name
- Alerta Gel Cushion EUDAMED
- Model / Reference
- ALT-204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614530565 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 GelCube 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 |
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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 9a7827bc-bab9-444f-9b53-7ef6762b2937 61 fields · synced Jul 24, 2026