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Cuvette (heparin)

by ARKRAY Factory, Inc. Japan EUDAMED

Ref 108238

EMDN W050301029099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987486BC0108238GZ Basic UDI-DIDate18 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
108238
Primary DI / UDI-DI
04987486039075
Basic UDI-DI
4987486BC0108238GZ
EMDN Code
W050301029099 Samples analyses, plastic containers - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
JP-MF-000003008
Authorised representative
ARKRAY Europe, B.V. NL-AR-000002056

Other devices from ARKRAY Factory, Inc.

See all devices from ARKRAY Factory, Inc. →

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 c66bd793-1ad7-4ab2-957f-d3c7cdc10bae 61 fields · synced 22 Oct 2026