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HS-Kit

by Omegametrix GmbH EUDAMED

Active European Union

Ref HSK01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426248751HSK0XBW Basic UDI-DIDate22 May 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  • Withdrawn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

Model / Reference
HSK01
Primary DI / UDI-DI
42624875100526
Basic UDI-DI
426248751HSK0XBW
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000052278

Other devices from Omegametrix GmbH

Properties

  • Human Tissues
  • Self Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No