Identity
- Trade Name
- Alerta Air Heel Bootees with Strap EUDAMED
- Device Name
- Alerta Air Heel Bootees with Strap EUDAMED
- Model / Reference
- ALT-210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060614530589 EUDAMED
- Basic UDI-DI
- 506061453AirBooteesX7 EUDAMED
- EMDN Code
- V0811 HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS 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 Air Heel Bootees with Strap 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 | 506061453AirBooteesX7 | 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 42916981-cff6-403d-a156-56bd5cd01d54 61 fields · synced Sep 30, 2026