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Viuick

by Guangzhou Viuick Biotechnology Co., LTD. China EUDAMED

Ref 48 Tests/Kit

EMDN W0105070504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975400320055 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 Enterovirus type 71/ Coxsackievirus type A16 RNA (Real-Time PCR Method)
Diagnostic Kit for Respiratory Syncytial Virus RNA (Real-Time PCR Method)
Model / Reference
48 Tests/Kit
Primary DI / UDI-DI
06975400320055, 06975400320116
Basic UDI-DI
B-06975400320055, B-06975400320116
EMDN Code
W0105070504, W0105040505
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
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 (2)

  • EUDAMED 5a683cac-b042-48a4-9c88-79e1fd628753 61 fields · synced 22 Oct 2026
  • EUDAMED 06975400320116|B-06975400320116 61 fields · synced 19 May 2026