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Thrombolyzer cuvette racks

by Kommanditgesellschaft Behnk Elektronik GmbH & Co. Germany EUDAMED

Ref 054520Model Thrombolyzer

EMDN W0202020185

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++EUBECOAFUTHRMCZA Basic UDI-DIDate19 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Cuvettes for pre-dilution
Model / Reference
Thrombolyzer, 054520
Primary DI / UDI-DI
+EUBE0545200/
Basic UDI-DI
++EUBECOAFUTHRMCZA
Direct Marketing DI
+EUBE0545200/
EMDN Code
W0202020185 Coagulometers - consumables
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
DE-MF-000005304

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED +EUBE0545200/|++EUBECOAFUTHRMCZA 61 fields · synced 25 Oct 2026