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GLUCOCARD W Control Solution

by ARKRAY Factory, Inc. EUDAMED

Active European Union

Ref 108487

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-108487NN Basic UDI-DIDate20 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
108487
Primary DI / UDI-DI
D-108487NN
Basic UDI-DI
B-108487NN
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD Annex II List B
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

  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No