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MicroScan LabPro v5 EU SMU Predictive Susceptibility (MR), Electronic

by Beckman Coulter Inc. United States EUDAMED

Ref D03455Model C82964 EMDN W0203010182

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15099501MCSWMN Basic UDI-DIDate28 Jul 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Microbiology Platform Product Family
Model / Reference
C82964, D03455
Primary DI / UDI-DI
15099590782559
Basic UDI-DI
15099501MCSWMN
Direct Marketing DI
15099590782559
EMDN Code
W0203010182 Antibiotic susceptibility analysers - software accessories
Device Class
Class A
Market of Registration
Spain

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • New Device
Other properties (9)
  • 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

Sources (1)

  • EUDAMED ad857db5-866b-4ea7-b2d7-16620cf22427 61 fields · synced 22 Oct 2026