Identity
- Trade Name
- Cuscino Kometair 1 (46x40x6) EUDAMED
- Device Name
- Cuscini antidecubito EUDAMED
- Model / Reference
- 855312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051381060727 EUDAMED
- Basic UDI-DI
- 805138106NV EUDAMED
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Cuscino Kometair 1 (46x40x6) by Rehasense Italy S.r.l. — 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 | 805138106NV | Class I | Active |
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Manufacturer
- Manufacturer
- Rehasense Italy S.r.l.
- EUDAMED SRN
- IT-MF-000037732
Sources (1)
- EUDAMED 35219d75-417c-4382-8d11-2e17c3d675f7 61 fields · synced Aug 3, 2026