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MicroScan Neg MIC EN 52

by Beckman Coulter Inc.

Ref B1016-195

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number15099501MCOVNEGQN Basic UDI-DI Date28 Feb 2023RegisteredStatusActive
European UnionCE/IVDR Number15099501MCOVNEGQN Basic UDI-DI Date28 Feb 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
MicroScan Neg MIC/Combo Panel Family
Model / Reference
B1016-195
Primary DI / UDI-DI
15099590690731, D-B1016-195SP
Basic UDI-DI
15099501MCOVNEGQN, B-B1016-195SP
Unit of Use DI
05099590690734
EMDN Code
W0203010185 Antibiotic susceptibility analysers - consumables
Device Class
Class B
Class IVD General
EU 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

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances
  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No