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Thrombolyzer XR

by Kommanditgesellschaft Behnk Elektronik GmbH & Co. EUDAMED

Active European Union

Ref 018012Model Thrombolyzer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++EUBECOAFUTHRRE Basic UDI-DIDate17 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Thrombolyzer XRS
Model / Reference
Thrombolyzer, 018012
Primary DI / UDI-DI
+EUBE0180120-
Basic UDI-DI
++EUBECOAFUTHRRE
Direct Marketing DI
+EUBE0180120-
EMDN Code
W0202020102 Automated coagulometers
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
DE-MF-000005304

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Properties

  • 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