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COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P)

by Hangzhou Clongene Biotech Co., Ltd.

Ref ICNA4002

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-ICOV400YS Basic UDI-DI D-ICOV400YSUDI-DIDate8 Aug 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  • Withdrawn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
ICNA4002
Primary DI / UDI-DI
D-ICOV400YS
Basic UDI-DI
B-ICOV400YS
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030069
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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