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SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)

by Nanjing Synthgene Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref RQ00501001HK

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473306577 Basic UDI-DIDate24 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
SARS-CoV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)
Model / Reference
RQ00501001HK
Primary DI / UDI-DI
06974473306577
Basic UDI-DI
B-06974473306577
EMDN Code
W0105040619
Device Class
Class IVD devices for self-testing
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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Properties

  • Reagent
  • Self Testing

Other properties (8)

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