Identity
- Device Name
- HELMET WITH AIR/OXYGEN BLENDING SYSTEM EUDAMED
- Model / Reference
- CVA108S/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323050020 EUDAMED
- Basic UDI-DI
- 80583230DCVENTUKIT2V EUDAMED
- Direct Marketing DI
- 08058323050020 EUDAMED
- EMDN Code
- R0301010401 CPAP HELMETS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania 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
Helmet With Air/Oxygen Blending System by Intersurgical SpA — 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 | 80583230DCVENTUKIT2V | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED 6f5d1c84-f431-4cc3-8a7c-e4b666ba9f6e 61 fields · synced Jul 30, 2026