Identity
- Trade Name
- mesh Nebulizer EUDAMED
- Device Name
- MESH Nebulizer EUDAMED
- Model / Reference
- NB-813B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384253290 EUDAMED
- Basic UDI-DI
- 697038425USNUE EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
mesh Nebulizer by HONSUN (NANTONG) Co., Ltd. — 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 | 697038425USNUE | Class IIa | Active |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009428
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 147c48c1-8ade-4433-b7e5-63e92e80666d 61 fields · synced Jun 19, 2026