Skip to content

Influenza A+B/COVID-19/ RSV Antigen Rapid Test

by Hangzhou Lysun Biotechnology Co., Ltd

Ref Influenza A+B/ COVID-19/ RSV Antigen Rapid Test

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-6971771200859 Basic UDI-DI 6971771200859UDI-DIDate26 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Influenza A+B/ COVID-19/ RSV Antigen Rapid Test
Primary DI / UDI-DI
6971771200859
Basic UDI-DI
B-6971771200859
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class IVD General
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
CN-MF-000010254
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hangzhou Lysun Biotechnology Co., Ltd

See all devices from Hangzhou Lysun Biotechnology Co., Ltd →

Properties

  • Reagent

Other properties (9)

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