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FUSIONPlex™-HT Dx Reagents 96rxn - B

by Integrated DNA Technologies EUDAMED

Active European Union

Ref 10029287Model FUSIONPlex™-HT Dx Reagents 96rxn - A

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081016358BUFDX27 Basic UDI-DIDate23 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
FUSIONPlex™-HT Dx Reagents
Model / Reference
FUSIONPlex™-HT Dx Reagents 96rxn - A, 10029287
Primary DI / UDI-DI
00810163580703
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000046709
Authorised representative
Integrated DNA Technologies B.V. BE-AR-000046392

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