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Automated Hematology Analyzer XP series, XP-300

by Sysmex Corporation EUDAMED

Active European Union

Ref AP807129Model XP-300

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04987562429172 Basic UDI-DIDate6 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Automated Hematology Analyzer XP series
Model / Reference
XP-300, AP807129
Primary DI / UDI-DI
04987562429172
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000014037
Authorised representative
Sysmex Europe SE DE-AR-000022333

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