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COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal gold）

by Tianjin Mingao Biotechnology Co.，ltd China EUDAMED

Ref Cassette EMDN W0103030402

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978168790009 Basic UDI-DIDate4 Feb 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal gold）
Model / Reference
Cassette
Primary DI / UDI-DI
06978168790009
Basic UDI-DI
B-06978168790009
EMDN Code
W0103030402 Control kits (immunohaematology)
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000045817
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Tianjin Mingao Biotechnology Co.，ltd

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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 667b69fa-5497-485f-95aa-b70e1493ea34 61 fields · synced 22 Oct 2026