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MicroScan Neg MIC EN 51

by Beckman Coulter Inc. United States EUDAMED

Ref B1016-194

EMDN W0203010185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number15099501MCOVNEGQN Basic UDI-DIDate28 Feb 2023RegisteredStatusActive
European UnionCE/IVDR Number15099501MCOVNEGQN Basic UDI-DIDate28 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
MicroScan Neg MIC/Combo Panel Family
Model / Reference
B1016-194
Primary DI / UDI-DI
15099590690724, D-B1016-194SM
Basic UDI-DI
15099501MCOVNEGQN, B-B1016-194SM
Unit of Use DI
05099590690727
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

Other devices from Beckman Coulter, Inc.

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • 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 ff1d58ec-4a80-4bcb-82a1-236856d964b8 61 fields · synced 22 Oct 2026
  • EUDAMED 8ccb1cc0-ffd0-4a7f-bf6e-14e219222163 61 fields · synced 17 May 2026