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2019-nCoV and Influenza A/B Combo Antigen Test Kit

by Beijing Diagreat Biotechnologies Co., Ltd.

Ref G11830Model 25 tests/box

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697518250G1183036 Basic UDI-DI 06942293581764UDI-DIDate5 Mar 2026RegisteredStatusActive

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  • Withdrawn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
25 tests/box, G11830
Primary DI / UDI-DI
06942293581764
Basic UDI-DI
697518250G1183036
Direct Marketing DI
06942293581764
EMDN Code
W0105070399 Multiple viruses - multiplex assays - other
Device Class
Class B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019511
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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