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iFOB control kit

by EUROLyser Diagnostica GmbH Austria EUDAMED

Ref ST2000 EMDN W0102160801

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ST2000D3 Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
ST2000
Primary DI / UDI-DI
D-ST2000D3
Basic UDI-DI
B-ST2000D3
EMDN Code
W0102160801 Controls immunochem - rt & poc
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000013746

Other devices from EUROLyser Diagnostica GmbH

See all devices from EUROLyser Diagnostica GmbH →

Properties & raw data

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

Sources (1)

  • EUDAMED e3ad6349-68d4-47a8-9d1c-87bf9db486ec 61 fields · synced 25 Oct 2026