Skip to content

Access HBs Ab

by Beckman Coulter Inc. United States EUDAMED

Ref A24296, A24298

EMDN W0105020204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-A24296UA Basic UDI-DIDate9 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Access HBs Ab
Access HBs Ab QC
Model / Reference
A24296, A24298
Primary DI / UDI-DI
D-A24296UA, D-A24298UE
Basic UDI-DI
B-A24296UA, B-A24298UE
EMDN Code
W0105020204, W0102152099
Device Class
Class IVD Annex II List A
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 NoEUDAMEDYesEUDAMED
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 8bb42130-53f1-4edd-a889-df49c44fd60a 61 fields · synced 22 Oct 2026
  • EUDAMED ae7556d4-4c9e-433d-b697-56045bb27f31 61 fields · synced 18 May 2026