Skip to content

SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit

by BioTeke Corporation（Wuxi）Co., Ltd

Ref ICA2114-11Model 20 tests/kit, 1 test/kit

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974541565639 Basic UDI-DI Date25 May 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  • Withdrawn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/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit
Model / Reference
20 tests/kit, ICA2114-11, 1 test/kit
Primary DI / UDI-DI
06974541565639, 06974541565622
Basic UDI-DI
B-06974541565639, B-06974541565622
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Croatia
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000007517
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Bioteke Corporation (Wuxi) Co., Ltd.

See all devices from Bioteke Corporation (Wuxi) Co., Ltd. →

Properties

  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED

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