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COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)

by Zhejiang Orient Gene Biotech Co., Ltd 5 variants

Ref GCFC-T502a-H5Model GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number69509960GCFC-T502a-HSQ Basic UDI-DI 06950996002318UDI-DIDate10 Nov 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
GCFC-T502a-H1， GCFC-T502a-H2， GCFC-T502a-H4， GCFC-T502a-H5， GCFC-T502a-H7 ，GCFC-T502a-H20, GCFC-T502a-H5
Primary DI / UDI-DI
06950996002318
Basic UDI-DI
69509960GCFC-T502a-HSQ
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
EU market of registration
France

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

Other properties (10)

  • 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
  • New Device: No