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BIOHIT FAEX Sample System

by Biohit Oyj Finland EUDAMED

Ref 602610

EMDN W05019001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6419587BFX010TC Basic UDI-DIDate30 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
602610
Primary DI / UDI-DI
06419587349008
Basic UDI-DI
6419587BFX010TC
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
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
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED b1309775-fc70-4b10-89fc-fb6a46f9809c 61 fields · synced 22 Oct 2026