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GastroPanel® quick test

by Biohit Oyj Finland EUDAMED

Ref 602320

EMDN W01021699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06419587023205 Basic UDI-DIDate20 Sep 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
602320
Primary DI / UDI-DI
06419587023205
Basic UDI-DI
B-06419587023205
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
FI-MF-000014642

Other devices from Biohit Oyj

See all devices from Biohit Oyj →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d23a3fbb-928a-4b31-8bbc-19d8de6b1478 61 fields · synced 22 Oct 2026