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Koagulometr CC-4000

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

Ref K104 EMDN W0202020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59007482463CC-4000UL Basic UDI-DIDate24 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
K104
Primary DI / UDI-DI
05900748246300
Basic UDI-DI
59007482463CC-4000UL
Direct Marketing DI
05900748246300
EMDN Code
W0202020101 Semi-automated coagulometers
Device Class
Class A
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
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 05900748246300|59007482463CC-4000UL 61 fields · synced 25 Oct 2026