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MicroScan MSF Neg/Pos ID Panel Type 2

by Beckman Coulter Inc. United States EUDAMED

Ref C38213

EMDN W0203010185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number15099501MCOVIDJR Basic UDI-DIDate13 Mar 2023RegisteredStatusActive
European UnionCE/IVDR Number15099501MCOVIDJR Basic UDI-DIDate13 Mar 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/Pos ID Panel Family
Model / Reference
C38213
Primary DI / UDI-DI
15099590729684, D-C38213VD
Basic UDI-DI
15099501MCOVIDJR, B-C38213VD
Unit of Use DI
05099590729687
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
  • 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 aba18af3-1a47-495f-be7a-8b40f2d031fb 61 fields · synced 22 Oct 2026
  • EUDAMED D-C38213VD|B-C38213VD 61 fields · synced 19 May 2026