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BONNET for NIV - LARGE SIZES KIT (2M +2 more)
EUDAMEDClass I (EU MDR)
Ref 11659H73Model BONNET for NIV - SMALL SIZES KIT (2XXS, 2XS, 2S)
by GINEVRI srl
Identity
- Trade Name
- BONNET for NIV - LARGE SIZES KIT (2M, 2L, 2XL) EUDAMED
- Device Name
- BONNET for NIV EUDAMED
- Model / Reference
- BONNET for NIV - SMALL SIZES KIT (2XXS, 2XS, 2S) EUDAMED11659H73 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053847360853 EUDAMED
- Basic UDI-DI
- 80538473637SX EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I 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
BONNET for NIV - LARGE SIZES KIT (2M +2 more) by GINEVRI srl — Class I — MDR — listed in EUDAMED — 3 models — 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 | 80538473637SX | Class I | Active |
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Manufacturer
- Manufacturer
- GINEVRI srl
- EUDAMED SRN
- IT-MF-000034527
Sources (1)
- EUDAMED 49d010b8-2293-41a7-91a3-aefd1c133219 61 fields · synced Jun 18, 2026