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Nebulizer
EUDAMEDClass IIa (EU MDR)
Ref M-0801-W-ENModel M-0801Ref M-0801-ENRef M-0701-ENModel M-0701
Identity
- Trade Name
- Nebulizer EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- M-0801 EUDAMEDM-0801-W-EN EUDAMEDM-0801-EN EUDAMEDM-0701 EUDAMEDM-0701-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894384474 EUDAMED04719875341373 EUDAMED04719875341441 EUDAMED
- Basic UDI-DI
- B-04719894384474 EUDAMEDB-04719875341373 EUDAMEDB-04719875341441 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nebulizer by VADI Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719894384474 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (3)
- EUDAMED e54d66c3-a80b-46ee-b9bf-a7ce11f14026 61 fields · synced Jul 22, 2026
- EUDAMED 40557d2c-123e-4713-bb22-94a14ffcc187 61 fields · synced May 16, 2026
- EUDAMED db8f08f1-03a2-4903-a9d6-897de1b5ebbb 61 fields · synced May 18, 2026