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Norovirus Test Kit (FIA)

by VivaChek Biotech (Hangzhou) Co., Ltd. EUDAMED

Active European Union

Ref VID178-01-011Model VID178

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06937339206763 Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
VID178, VID178-01-011
Primary DI / UDI-DI
06937339206763
Basic UDI-DI
B-06937339206763
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from VivaChek Biotech (Hangzhou) Co., Ltd.

See all devices from VivaChek Biotech (Hangzhou) Co., Ltd. →

Properties

  • 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