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Viuick

by Guangzhou Viuick Biotechnology Co., LTD. China EUDAMED

Ref 48 Tests/Kit

EMDN W0104080207

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975400320048 Basic UDI-DIDate15 May 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

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
  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED
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 61 fields · synced 22 Oct 2026
  • EUDAMED 06975400320017|B-06975400320017 61 fields · synced 17 May 2026
  • EUDAMED 06975400320031|B-06975400320031 61 fields · synced 17 May 2026
  • EUDAMED 06975400320093|B-06975400320093 61 fields · synced 17 May 2026
  • EUDAMED 06975400320154|B-06975400320154 61 fields · synced 19 May 2026
  • EUDAMED 06975400320062|B-06975400320062 61 fields · synced 19 May 2026
  • EUDAMED 06975400320130|B-06975400320130 61 fields · synced 19 May 2026
  • EUDAMED 06975400320123|B-06975400320123 61 fields · synced 19 May 2026
  • EUDAMED 06975400320000|B-06975400320000 61 fields · synced 19 May 2026
  • EUDAMED 06975400320024|B-06975400320024 61 fields · synced 19 May 2026
  • EUDAMED 06975400320086|B-06975400320086 61 fields · synced 19 May 2026