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Respireo SOFT Facial Non Vented
EUDAMEDClass IIa (EU MDR)
Ref 472553Ref 472551Ref 472552
Identity
- Trade Name
- Respireo SOFT Facial Non Vented EUDAMED
- Device Name
- Respireo SOFT Facial Non Vented EUDAMED
- Model / Reference
- 472553 EUDAMED472551 EUDAMED472552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662725538 EUDAMED08015662725514 EUDAMED08015662725521 EUDAMED
- Basic UDI-DI
- 8015662RESPSOFTFNVBD EUDAMED
- EMDN Code
- R0301010202 NIV 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
Category: Rebreathing oxygen face mask
Respireo SOFT Facial Non Vented by Air Liquide Medical Systems S.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 8015662RESPSOFTFNVBD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (3)
- EUDAMED 168207fd-a08b-4024-b7d8-a5d4496145d5 61 fields · synced Oct 6, 2026
- EUDAMED 21b891a5-5659-4254-983e-978544707a9b 61 fields · synced May 17, 2026
- EUDAMED 83e3abd8-162e-4665-8a99-389980f2afdf 61 fields · synced May 17, 2026