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Influenza A&B Rapid Test Kit (Colloidal Gold)

by Jiangsu Konsung Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref ICMAB-502G-2, ICMAB-502G-1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975132462023 Basic UDI-DIDate26 May 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Influenza A&B Rapid Test Kit (Colloidal Gold)
Model / Reference
ICMAB-502G-2, ICMAB-502G-1
Primary DI / UDI-DI
06975132462023, 06975132462016
Basic UDI-DI
B-06975132462023, B-06975132462016
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000004533
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No