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Behnk

by Kommanditgesellschaft Behnk Elektronik GmbH & Co. EUDAMED

Active European Union

Ref 050210, 691284, 050280Model Thrombotimer, Thrombolyzer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++EUBECOASETRTMC4A Basic UDI-DIDate19 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  • Withdrawn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
Cuvette racks & balls
5-fold sample rack
Cuvettes for pre-dilution
Model / Reference
Thrombotimer, 050210, Thrombolyzer, 691284, 050280
Primary DI / UDI-DI
+EUBE0502100/$P, +EUBE6912840/$4, +EUBE0502800/$W
Basic UDI-DI
++EUBECOASETRTMC4A, ++EUBECOAFUTHRMAZ6, ++EUBECOAFUTHRMCZA
EMDN Code
W0202020185, W0202020180
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005304

Other devices from Kommanditgesellschaft Behnk Elektronik GmbH & Co.

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Properties

  • 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