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Bio-Ksel PT plus

by "Bio-Ksel" Sp. z o.o. Poland EUDAMED

Ref 843 522 EMDN W0103020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05902186655218 Basic UDI-DIDate4 May 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
843 522
Primary DI / UDI-DI
05902186655218
Basic UDI-DI
B-05902186655218
EMDN Code
W0103020101 Prothrombin time ( quick test )
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000004774

Other devices from "Bio-Ksel" Sp. z o.o.

See all devices from "Bio-Ksel" Sp. z o.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c4ef7dd4-2381-4879-be80-043fdd9b0d73 61 fields · synced 22 Oct 2026