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Influenza A/B Antigen Rapid Test

by Medotex Biotech (HangZhou) Co., Ltd. EUDAMED

Active European Union

Ref FLU-522b-25MModel FLU-522b

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69798909110006CP Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
FLU-522b, FLU-522b-25M
Primary DI / UDI-DI
06979890910673
Basic UDI-DI
69798909110006CP
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051631
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Medotex Biotech (HangZhou) Co., Ltd.

See all devices from Medotex Biotech (HangZhou) Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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