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PT (INR) test kit (32 tests)

by EUROLyser Diagnostica GmbH Austria EUDAMED

Ref ST0180

EMDN W0103020801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ST0180DJ Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

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
ST0180
Primary DI / UDI-DI
D-ST0180DJ
Basic UDI-DI
B-ST0180DJ
EMDN Code
W0103020801 Prothrombin time 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
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 1070f062-7f95-4b74-b50a-616415b558e8 61 fields · synced 22 Oct 2026