Identity
- Trade Name
- Soffio Cube EUDAMED
- Device Name
- Soffio Cube EUDAMED
- Model / Reference
- 404104 EUDAMED404105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08015662041041 EUDAMED08015662041058 EUDAMED
- Basic UDI-DI
- 8015662SOFFIOCUBE9P EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soffio Cube 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 | 8015662SOFFIOCUBE9P | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Liquide Medical Systems S.r.l.
- EUDAMED SRN
- IT-MF-000015627
Sources (2)
- EUDAMED 5aa04fa5-f14e-413c-a3a2-aeb4e85b8f97 61 fields · synced Oct 6, 2026
- EUDAMED 79112ab9-35bd-43c0-bb6a-f99d95247f29 61 fields · synced May 18, 2026