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MicroScan MICroSTREP plus Panel Type 6

by Beckman Coulter Inc. EUDAMED

Active European Union

Ref B1016-170

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number15099501MCSTREPSS Basic UDI-DIDate13 Mar 2023RegisteredStatusActive
European UnionCE/IVDR Number15099501MCSTREPSS Basic UDI-DIDate13 Mar 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

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.

Specification

EUDAMED

Device Name
MicroScan MICroSTREP plus Panel Family
Model / Reference
B1016-170
Primary DI / UDI-DI
15099590656706, D-B1016-170S7
Basic UDI-DI
15099501MCSTREPSS, B-B1016-170S7
Unit of Use DI
05099590656709
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

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • 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