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Cuvettes and balls

by Kommanditgesellschaft Behnk Elektronik GmbH & Co. EUDAMED

Active European Union

Ref 050150Model Cuvettes and balls

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++EUBECOASETRCMCZJ Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Cuvettes and balls, 050150
Primary DI / UDI-DI
+EUBE0501500Z
Basic UDI-DI
++EUBECOASETRCMCZJ
Direct Marketing DI
+EUBE0501500Z
EMDN Code
W0202020185 Coagulometers - consumables
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
DE-MF-000005304

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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