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SARS-CoV-2 Antigen Kit (Colloidal Gold) (for self-testing)

by Goldsite Diagnostics Inc. China EUDAMED

Ref CG123025 EMDN W0105070304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971225931674 Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
CG123025
Primary DI / UDI-DI
06971225931674
Basic UDI-DI
B-06971225931674
EMDN Code
W0105070304 Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex na reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001353
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Goldsite Diagnostics Inc.

See all devices from Goldsite Diagnostics Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
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

Sources (1)

  • EUDAMED c39f5ae9-ca59-410e-bc26-b14eb89ddf4a 61 fields · synced 25 Oct 2026