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Access Vitamin B12 II Calibrators

by Beckman Coulter Inc. United States EUDAMED

Ref D06116 EMDN W0102152206

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number150995907AccVB12CalRT Basic UDI-DIDate7 Mar 2024RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
D06116
Primary DI / UDI-DI
15099590786519, 15099590818401
Basic UDI-DI
150995907AccVB12CalRT, 150995909AccVB12IICalRK
EMDN Code
W0102152206 Anaemia related/vitamin standards and calibrators
Device Class
Class B
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED a3d125ab-a86a-4fa0-9a91-c4813e956ea7 61 fields · synced 22 Oct 2026
  • EUDAMED 15099590818401|150995909ACCVB12IICALRK 61 fields · synced 24 Oct 2026