Skip to content

MicroScan HighFlexX Software v2.9, Electronic

by Beckman Coulter Inc. United States EUDAMED

Ref C54389

EMDN W0203010192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15099501MCBSESWLF Basic UDI-DIDate24 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Microbiology Standalone Software Products
Model / Reference
C54389
Primary DI / UDI-DI
15099590738099
Basic UDI-DI
15099501MCBSESWLF
Direct Marketing DI
15099590738099
EMDN Code
W0203010192 Antibiotic susceptibility analysers - IVD medical device software
Device Class
Class B
Special Device Type
Software
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
  • 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 fa400072-e6bf-4222-9c3c-0bd6af87bada 61 fields · synced 22 Oct 2026