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COVID-19 Antigen Rapid Test. Self Test

by Biolan Microbiosensores S.L. Spain EUDAMED

Ref KASTCOV19-1 EMDN W01010699

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08437022705118 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
KASTCOV19-1
Primary DI / UDI-DI
08437022705118
Basic UDI-DI
B-08437022705118
EMDN Code
W01010699 Clin. chem. rt & poc - other
Device Class
Class IVD devices for self-testing
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001992

Other devices from Biolan Microbiosensores S.L.

See all devices from Biolan Microbiosensores S.L. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8c87a1de-25d9-40f2-9663-1c0f0b3d2203 61 fields · synced 22 Oct 2026