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GastroSoft

by Biohit Oyj Finland EUDAMED

Ref 740193

EMDN W0201020292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06419587740195 Basic UDI-DIDate23 Aug 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
740193
Primary DI / UDI-DI
06419587740195
Basic UDI-DI
B-06419587740195
EMDN Code
W0201020292 Limited panel immunochemistry analysers - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Finland

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
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED b57d011b-7e15-49fe-b8e8-564756ccb074 61 fields · synced 22 Oct 2026