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MicroScan Neg Combo Panel Type 54

by Beckman Coulter Inc. United States EUDAMED

Ref B1016-143

EMDN W0203010185

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-B1016-143S4 Basic UDI-DIDate8 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

Device Name
MicroScan Neg MIC/Combo Panel Family
Model / Reference
B1016-143
Primary DI / UDI-DI
D-B1016-143S4, 15099590656454
Basic UDI-DI
B-B1016-143S4, 15099501MCOVNEGQN
Unit of Use DI
05099590656457
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
Device Class
Class IVD General
Class B
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 NoEUDAMEDYesEUDAMED
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • 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 d932672e-e155-4eac-aab7-a8d048c26dd6 61 fields · synced 22 Oct 2026
  • EUDAMED 15099590656454|15099501MCOVNEGQN 61 fields · synced 19 May 2026