Identity
- Trade Name
- Cuscino Kometair 2(40x40x10) EUDAMED
- Device Name
- Cuscini antidecubito EUDAMED
- Model / Reference
- 855340 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051381060635 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 2(40x40x10) 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 d4ccbe2a-5448-42bb-b7b7-e2e6abb44dc3 61 fields · synced Jul 20, 2026