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COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

by Healgen Scientific Limited Liability Company 2 variants

Ref GCCOV-402a

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-GCCOV-402aHG43 Basic UDI-DI D-GCCOV-402aHG43UDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
GCCOV-402a
Primary DI / UDI-DI
D-GCCOV-402aHG43
Basic UDI-DI
B-GCCOV-402aHG43
EMDN Code
W0105090502 Coronavirus antibody (ab) - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

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