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MicroScan Pos Breakpoint Combo Panel Type 32

by Beckman Coulter Inc. United States EUDAMED

Ref B1016-152

EMDN W0203010185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number15099501MCOVPOSSN Basic UDI-DIDate13 Mar 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
MicroScan Pos MIC/Combo Panel Family
Model / Reference
B1016-152
Primary DI / UDI-DI
15099590656522, D-B1016-152S5
Basic UDI-DI
15099501MCOVPOSSN, B-B1016-152S5
Unit of Use DI
05099590656525
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
Device Class
Class B
Class IVD General
Market of Registration
Ireland

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
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 6625a5fe-f32f-4ccd-aced-65d7850e69e7 61 fields · synced 22 Oct 2026
  • EUDAMED D-B1016-152S5|B-B1016-152S5 61 fields · synced 19 May 2026