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COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

by Anhui Deepblue Medical Technology Co., Ltd 8 variants

Ref COVAg1NNO3-15Model Cassette

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 Number69520627J013L5 Basic UDI-DI 06952062713913UDI-DIDate7 Aug 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  • Withdrawn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
Cassette, COVAg1NNO3-15
Primary DI / UDI-DI
06952062713913
Basic UDI-DI
69520627J013L5
Unit of Use DI
06952062713944
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018785
Authorised representative
Mega Eurostar Sp. z o.o. PL-AR-000042730

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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