Identity
- Device Name
- HELMETS FOR NON INVASIVE VENTILATION EUDAMED
- Model / Reference
- CP211XS/2RW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323003682 EUDAMED
- Basic UDI-DI
- 80583230DCCASCHIKD EUDAMED
- Direct Marketing DI
- 08058323003682 EUDAMED
- EMDN Code
- R0301010402 NIV 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
Helmets For Non Invasive Ventilation 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 | 80583230DCCASCHIKD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED c3a5a74b-1933-4bbe-b329-ad09568aa7dd 61 fields · synced Sep 17, 2026