Identity
- Trade Name
- Respireo SOFT Facial EUDAMED
- Device Name
- Respireo SOFT Facial EUDAMED
- Model / Reference
- 472550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662725507 EUDAMED
- Basic UDI-DI
- 8015662RESPSOFTFVH EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
Respireo SOFT Facial by Air Liquide Medical Systems S.r.l. — Class IIa — 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 | 8015662RESPSOFTFVH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (1)
- EUDAMED 3e83416f-d385-4f78-a6a7-8d46bb8b4102 61 fields · synced Jun 19, 2026