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Rapid Flu A&B+RSV+Adeno Antigen Test

by Zhejiang Orient Gene Biotech Co., Ltd 4 variants

Ref GCFRA-T525a-DRH20Model GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69509960GCFRA-T525aDRH3A Basic UDI-DI 06950996004114UDI-DIDate5 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 092305 0014 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  • Withdrawn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
GCFRA-T525a-DRH1/GCFRA-T525a-DRH5/GCFRA-T525a-DRH7/GCFRA-T525a-DRH20, GCFRA-T525a-DRH20
Primary DI / UDI-DI
06950996004114
Basic UDI-DI
69509960GCFRA-T525aDRH3A
EMDN Code
W0105099099 Virology - rt & poc - other
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

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

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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