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Wellion
EUDAMEDClass IIa (EU MDR)
Ref KFT-03/6943532400068Model KFT-01、KFT-02、KFT-03、KFT-04、KFT-05、KFT-05、KFT-07、KFT-08、KFT-09、KFT-10、KFT-11、KFT-12、KFT-13、KFT-14、KFT-15、KFT-16、KFT-17、KFT-18、KFT-19、KFT-20
Identity
- Trade Name
- Wellion EUDAMED
- Device Name
- Digital thermometer EUDAMED
- Model / Reference
- KFT-01、KFT-02、KFT-03、KFT-04、KFT-05、KFT-05、KFT-07、KFT-08、KFT-09、KFT-10、KFT-11、KFT-12、KFT-13、KFT-14、KFT-15、KFT-16、KFT-17、KFT-18、KFT-19、KFT-20 EUDAMEDKFT-03/6943532400068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943532400068 EUDAMED
- Basic UDI-DI
- 69435324DTCNMF000019108BL EUDAMED
- Direct Marketing DI
- 06943532400068 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wellion by Kangfu Medical Equipment Factory — 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 | 69435324DTCNMF000019108BL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kangfu Medical Equipment Factory
- EUDAMED SRN
- CN-MF-000019108
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a513be39-8763-434f-8669-c8752da921ca 61 fields · synced Jun 19, 2026