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Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)

by Xiamen Wiz Biotech Co., Ltd.

Ref 52330701,52330705,52330720,52330725

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-523307NY Basic UDI-DI D-523307NYUDI-DIDate9 Sep 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Diagnostic Kit for Antigen to Helicobacter Pylori (Fluorescence Immunochromatographic Assay)
Model / Reference
52330701, 52330705, 52330720, 52330725
Primary DI / UDI-DI
D-523307NY
Basic UDI-DI
B-523307NY
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000029590
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Xiamen Wiz Biotech Co., Ltd.

See all devices from Xiamen Wiz Biotech 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