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MicroScan Neg MIC 57

by Beckman Coulter Inc. United States EUDAMED

Ref C58012

EMDN W0104080101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-C58012VP Basic UDI-DIDate8 Jun 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-C58012VP Basic UDI-DIDate8 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

Device Name
MicroScan Neg MIC/Combo Panel Family
Model / Reference
C58012
Primary DI / UDI-DI
D-C58012VP, 15099590738235
Basic UDI-DI
B-C58012VP, 15099501MCOVNEGQN
Unit of Use DI
05099590738238
EMDN Code
W0104080101, W0203010185
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.

See all devices from Beckman Coulter, Inc. →

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 a913b596-3907-46b1-89f0-153e8f0d14c4 61 fields · synced 22 Oct 2026
  • EUDAMED 15099590738235|15099501MCOVNEGQN 61 fields · synced 17 May 2026