Identity
- Trade Name
- Respireo SOFT Child EUDAMEDRespireo SOFT Child Non Vented EUDAMED
- Device Name
- Respireo SOFT Child EUDAMEDRespireo SOFT Child Non Vented EUDAMED
- Model / Reference
- 472711 EUDAMED472712 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662727112 EUDAMED08015662727129 EUDAMED
- Basic UDI-DI
- 8015662RESPSOFTCHILDE7 EUDAMED8015662RESPSOFTCHILDNV3E EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMEDR0301010202 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
Respireo SOFT Child 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 | 8015662RESPSOFTCHILDE7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (2)
- EUDAMED 51d11044-650c-4d1e-bed2-a23e463dc619 61 fields · synced Oct 5, 2026
- EUDAMED 3a812e6a-c3cd-404e-a54d-8a18e4e8f8dc 61 fields · synced May 19, 2026