Viuick
by Guangzhou Viuick Biotechnology Co., LTD. China EUDAMED
Ref 48 Tests/Kit
EMDN W0104080207
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975400320048 | Date15 May 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Diagnostic Kit for Ureaplasma Urealyticum DNA (Real-Time PCR Method)Diagnostic Kit for Dengue Virus RNA (Real-Time PCR Method)Diagnostic Kit for Zika /Dengue /Chikungunya virus RNA (Real-Time PCR Method)Diagnostic Kit for Mycoplasma Pneumoniae DNA (Real-Time PCR Method)Diagnostic Kit for Human Papilloma Virus 14 High-Risk Genotyping DNA (Real-Time PCR Method)Diagnostic Kit for Salmonella DNA (Real-Time PCR Method)Diagnostic Kit for Herpes simplex virus type 1/2 DNA (Real-Time PCR Method)Diagnostic Kit for Influenza A virus/Influenza B virus RNA (Real-Time PCR Method)Diagnostic Kit for Dengue Virus type I/II/III/IV RNA (Real-Time PCR Method)Diagnostic Kit for Japanese Encephalitis Virus RNA (Real-Time PCR Method)Diagnostic Kit for Mycobacterium Tuberculosis DNA (Real-Time PCR Method)
- Model / Reference
- 48 Tests/Kit
- Primary DI / UDI-DI
- 06975400320048, 06975400320017, 06975400320031, 06975400320093, 06975400320154, 06975400320062, 06975400320130, 06975400320123, 06975400320000, 06975400320024, 06975400320086
- Basic UDI-DI
- B-06975400320048, B-06975400320017, B-06975400320031, B-06975400320093, B-06975400320154, B-06975400320062, B-06975400320130, B-06975400320123, B-06975400320000, B-06975400320024, B-06975400320086
- EMDN Code
- W0104080207, W0105040511, W0105070399, W0105010801,W0105010802,W0105010803,W0105010899, W0105041002, W0105011003, W0105040311, W0105040604, W0105070505, W0105010703
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000017369
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guangzhou Viuick Biotechnology Co., LTD.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (11)
- EUDAMED 360615aa-6454-4cfb-904d-9a61fbad5544
- EUDAMED 06975400320017|B-06975400320017
- EUDAMED 06975400320031|B-06975400320031
- EUDAMED 06975400320093|B-06975400320093
- EUDAMED 06975400320154|B-06975400320154
- EUDAMED 06975400320062|B-06975400320062
- EUDAMED 06975400320130|B-06975400320130
- EUDAMED 06975400320123|B-06975400320123
- EUDAMED 06975400320000|B-06975400320000
- EUDAMED 06975400320024|B-06975400320024
- EUDAMED 06975400320086|B-06975400320086