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PT (INR) control kit

by EUROLyser Diagnostica GmbH Austria EUDAMED

Ref ST1800

EMDN W010302080501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ST1800E4 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
ST1800
Primary DI / UDI-DI
D-ST1800E4
Basic UDI-DI
B-ST1800E4
EMDN Code
W010302080501 Hemostasis controls 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
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED f17b9167-6bdd-400c-9093-1643e15e69b5 61 fields · synced 22 Oct 2026