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Access GI Monitor Calibrators

by Beckman Coulter Inc. EUDAMED

Active European Union

Ref 687688Model 387688

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995909AccGIMonCalQX Basic UDI-DIDate31 Aug 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  • Withdrawn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
387688, 687688
Primary DI / UDI-DI
15099590817077
Basic UDI-DI
150995909AccGIMonCalQX
EMDN Code
W0102152205 Tumour marker standards and calibrators
Device Class
Class C
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000051071
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

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