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Rapid Influenza A & B Antigen Test

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref GCFLU(A/B)-502a-DRH2Model 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

Regulatory status

as of 27 Oct 2026

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 092305 0013 Issued

    Technical documentation EU IVDR

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

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
06950996002615
Basic UDI-DI
69509960GCFLUAB502aDRHGQ
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class C
Market of Registration
Germany

Manufacturer details

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

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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