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Heated Wire (Without Port)
EUDAMEDClass IIb (EU MDR)
Ref 900110LE-ENModel 900110LERef 900130LE-ENModel 900130LERef 900045-ENModel 900045Ref 900150LE-ENModel 900150LE
Identity
- Trade Name
- Heated Wire (Without Port) EUDAMEDHeated Wire EUDAMED
- Device Name
- Respiratory Humidifier EUDAMEDBacteria Filter Heater and Accessories EUDAMED
- Model / Reference
- 900110LE EUDAMED900110LE-EN EUDAMED900130LE EUDAMED900130LE-EN EUDAMED900045 EUDAMED900045-EN EUDAMED900150LE EUDAMED900150LE-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875347818 EUDAMED04719875347849 EUDAMED04719875340239 EUDAMED04719875347870 EUDAMED
- Basic UDI-DI
- B-04719875347818 EUDAMEDB-04719875347849 EUDAMEDB-04719875340239 EUDAMEDB-04719875347870 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMEDR040199 VENTILATION FILTERS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass 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
Category: Tracheostomy tube speech valve
Heated Wire (Without 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-04719875347818 | 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 (4)
- EUDAMED 42790df1-2888-42d9-be85-c7d3ef497288 61 fields · synced Jul 30, 2026
- EUDAMED f777b1fb-50f4-4048-a31b-37281050ab55 61 fields · synced May 17, 2026
- EUDAMED 88a0e639-6382-4368-9491-48444ed7254c 61 fields · synced May 17, 2026
- EUDAMED 5e8d5db8-517d-4baa-b4da-333e4f40da85 61 fields · synced May 19, 2026