Identity
- Trade Name
- Nebucare In-line Electrical Nebulizer EUDAMED
- Device Name
- Nebucare In-line Electrical Nebulizer EUDAMED
- Model / Reference
- GUN-300vt EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970966662847 EUDAMED
- Basic UDI-DI
- 6970966660130E5 EUDAMED
- Direct Marketing DI
- 06970966662847 EUDAMED
- EMDN Code
- R03010399 AEROSOL THERAPY SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Nebucare In-line Electrical Nebulizer by Gentec (shanghai) Corporation — 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 | 6970966660130E5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gentec (Shanghai) Corporation
- EUDAMED SRN
- CN-MF-000012841
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 62dacf0e-4d71-4e2b-b8da-e9396658f574 61 fields · synced Jul 11, 2026