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Heated Wire (With Port)
EUDAMEDClass IIb (EU MDR)
Ref 900150L-ENModel 900150LRef 900110L-ENModel 900110LRef 900130L-ENModel 900130L
Identity
- Trade Name
- Heated Wire (With Port) EUDAMED
- Device Name
- Respiratory Humidifier EUDAMED
- Model / Reference
- 900150L EUDAMED900150L-EN EUDAMED900110L EUDAMED900110L-EN EUDAMED900130L EUDAMED900130L-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875347788 EUDAMED04719875347726 EUDAMED04719875347757 EUDAMED
- Basic UDI-DI
- B-04719875347788 EUDAMEDB-04719875347726 EUDAMEDB-04719875347757 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
Category: Tracheostomy tube speech valve
Heated Wire (With Port) by VADI Medical Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04719875347788 | Class IIb | 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 32327060-be8a-48f8-9cc0-e8e0721956e1 61 fields · synced Jul 20, 2026
- EUDAMED 77b557c8-44e3-4129-9592-ec22422ad704 61 fields · synced May 18, 2026
- EUDAMED 32ac43aa-bdeb-41fd-bf66-f07a0460a511 61 fields · synced May 18, 2026