Skip to content

SARS-CoV-2 Antigen Rapid Test

by Xiamen Wiz Biotech Co., Ltd.

Ref 51832801,51832810,51832825,51832800,51832802,51832803,51832804,51832806,51832821,51832831,51832845,51832823,51832811

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-518328PY Basic UDI-DI D-518328PYUDI-DIDate8 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  • Withdrawn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
Model / Reference
51832801, 51832810, 51832825, 51832800, 51832802, 51832803, 51832804, 51832806, 51832821, 51832831, 51832845, 51832823, 51832811
Primary DI / UDI-DI
D-518328PY
Basic UDI-DI
B-518328PY
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class IVD General
EU market of registration
Belgium

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