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Rapid Influenza A & B Antigen Test

by Zhejiang Orient Gene Biotech Co., Ltd 5 variants

Ref GCFLU(A/B)-502a-DRH7Model GCFLU(A/B)-502a-DRH1,GCFLU(A/B)-502a-DRH2,GCFLU(A/B)-502a-DRH5,GCFLU(A/B)-502a-DRH7,GCFLU(A/B)-502a-DRH20

Active European Union

CE IVDR

Valid until

17 Apr 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69509960GCFLUAB502aDRHGQ Basic UDI-DI 06950996002639UDI-DIDate6 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 092305 0013 Active

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    8 Jun 2026
    Expires
    17 Apr 2030
    Valid from
    30 Jun 2026

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
GCFLU(A/B)-502a-DRH1, GCFLU(A/B)-502a-DRH2, GCFLU(A/B)-502a-DRH5, GCFLU(A/B)-502a-DRH7, GCFLU(A/B)-502a-DRH20
Primary DI / UDI-DI
06950996002639
Basic UDI-DI
69509960GCFLUAB502aDRHGQ
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Reagent
  • Self Testing

Other properties (9)

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