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COVID-19 lgG/IgM Rapid Test Cassette

by Biolan Microbiosensores S.L. EUDAMED

Active European Union

Ref KSCOV19

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08437022705019 Basic UDI-DIDate27 Jun 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  • Withdrawn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

Model / Reference
KSCOV19
Primary DI / UDI-DI
08437022705019
Basic UDI-DI
B-08437022705019
EMDN Code
W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001992

Other devices from Biolan Microbiosensores S.L.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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