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Neg Combo Panel Type 66

by Beckman Coulter Inc. United States EUDAMED

Ref B1016-171

EMDN W0203010185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-B1016-171S9 Basic UDI-DIDate9 Jun 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-B1016-171S9 Basic UDI-DIDate9 Jun 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Neg Combo Panel Type 66
MicroScan Neg Combo Panel Type 66
Device Name
MicroScan Neg MIC/Combo Panel Family
Model / Reference
B1016-171
Primary DI / UDI-DI
D-B1016-171S9, 15099590656713
Basic UDI-DI
B-B1016-171S9, 15099501MCOVNEGQN
Unit of Use DI
05099590656716
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

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • 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 6b1e7b4d-2fc3-41bf-b39f-0b70d8431f4f 61 fields · synced 22 Oct 2026
  • EUDAMED 15099590656713|15099501MCOVNEGQN 61 fields · synced 19 May 2026