Skip to content

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

by Xiamen Wiz Biotech Co., Ltd.

Ref 51232801,51232803,51232809,51232811,51232805,51232807,51232802,51232804,51232810,51232812,51232806,51232808Model Type A, Type B

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-512328NN Basic UDI-DI D-512328NNUDI-DIDate14 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  • Withdrawn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
SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)
Model / Reference
Type A, Type B, 51232801, 51232803, 51232809, 51232811, 51232805, 51232807, 51232802, 51232804, 51232810, 51232812, 51232806, 51232808
Primary DI / UDI-DI
D-512328NN
Basic UDI-DI
B-512328NN
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class IVD General
EU market of registration
Poland

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