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Reusable Humidifier Chamber
EUDAMEDClass IIa (EU MDR)
Ref G-314002-ENModel G-314002Ref G-314001-B-EN1Model G-314001-BRef G-314003-ENModel G-314003Ref G-314005-ENModel G-314005
Identity
- Trade Name
- Reusable Humidifier Chamber EUDAMEDHumidifier Chamber EUDAMED
- Device Name
- Reusable Humidifier Chamber EUDAMEDHumidifier Chamber EUDAMED
- Model / Reference
- G-314002 EUDAMEDG-314002-EN EUDAMEDG-314001-B EUDAMEDG-314001-B-EN1 EUDAMEDG-314003 EUDAMEDG-314003-EN EUDAMEDG-314005 EUDAMEDG-314005-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875346446 EUDAMED04719875343995 EUDAMED04719875346453 EUDAMED04719875346507 EUDAMED
- Basic UDI-DI
- B-04719875346446 EUDAMEDB-04719875343995 EUDAMEDB-04719875346453 EUDAMEDB-04719875346507 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia EUDAMEDTürkiye 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
Reusable Humidifier Chamber 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-04719875346446 | 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 (4)
- EUDAMED ef4dce06-f7a7-44c3-ae49-80dbb2e91a2d 61 fields · synced Jul 19, 2026
- EUDAMED de655470-ea09-4b7f-b85f-f00408310e65 61 fields · synced May 17, 2026
- EUDAMED 21fb1e53-127c-465e-a61b-d9ca13e93070 61 fields · synced May 17, 2026
- EUDAMED e787103b-8f12-4cc8-827d-d75f3ff1d06b 61 fields · synced May 18, 2026