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Respireo SOFT Facial
EUDAMEDClass IIa (EU MDR)
Ref 472559Ref 472548Ref 472536Ref 472557
Identity
- Trade Name
- Respireo SOFT Facial EUDAMED
- Device Name
- Respireo SOFT Facial EUDAMED
- Model / Reference
- 472559 EUDAMED472548 EUDAMED472536 EUDAMED472557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662725590 EUDAMED08015662725484 EUDAMED08015662725361 EUDAMED08015662725576 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 (4)
- EUDAMED 286c0c96-5cde-4695-b6ce-8db407b76f12 61 fields · synced Oct 6, 2026
- EUDAMED 97b9dd02-569f-48f1-9fdb-ce89e8bb1c13 61 fields · synced May 18, 2026
- EUDAMED 35d73bfc-0253-4a7a-b3e2-59c4e5e5b260 61 fields · synced May 18, 2026
- EUDAMED 152fbbc5-d40b-4aa6-999e-afb533f7407a 61 fields · synced May 18, 2026