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HEV IgM Rapid Test

by VivaChek Biotech (Hangzhou) Co., Ltd.

Ref VIHE-402Model VIHE

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-VIHE-402LJ Basic UDI-DI Date14 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
VIHE-402, VIHE
Primary DI / UDI-DI
D-VIHE-402LJ, 06937339209566
Basic UDI-DI
B-VIHE-402LJ, B-06937339209566
EMDN Code
W0105090299 Hepatitis viruses - rt & poc - other
Device Class
Class IVD General
EU market of registration
Netherlands
Italy

Manufacturer details

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

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Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No