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Respireo SOFT Baby Non Vented
EUDAMEDClass IIa (EU MDR)
Ref 472717Ref 472705Ref 472703
Identity
- Trade Name
- Respireo SOFT Baby Non Vented EUDAMEDRespireo SOFT Baby EUDAMED
- Device Name
- Respireo SOFT Baby Non Vented EUDAMEDRespireo SOFT Baby EUDAMED
- Model / Reference
- 472717 EUDAMED472705 EUDAMED472703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662727174 EUDAMED08015662727051 EUDAMED08015662727037 EUDAMED
- Basic UDI-DI
- 8015662RESPSOFTBABYNVLX EUDAMED8015662RESPSOFTBABYA2 EUDAMED
- EMDN Code
- R0301010202 NIV MASKS EUDAMEDR0301010201 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
Category: Rebreathing oxygen face mask
Respireo SOFT Baby 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 | 8015662RESPSOFTBABYNVLX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (3)
- EUDAMED d0767adb-29c7-442d-a378-3a8c4daa39e0 61 fields · synced Jul 22, 2026
- EUDAMED e77428ff-cb59-45dc-9977-ceacbb5aea68 61 fields · synced May 18, 2026
- EUDAMED b0c162cb-082c-4db8-933b-96632ef46c9a 61 fields · synced May 18, 2026