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FUSIONPlex™-HT Dx Reagents 24rxn - B

by Integrated DNA Technologies United States EUDAMED

Ref 10029289Model FUSIONPlex™-HT Dx Reagents 96rxn - A EMDN W0599

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
FUSIONPlex™-HT Dx Reagents
Model / Reference
FUSIONPlex™-HT Dx Reagents 96rxn - A, 10029289
Primary DI / UDI-DI
00810163580727
Basic UDI-DI
081016358BUFDX27
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

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

Other devices from Integrated DNA Technologies

See all devices from Integrated DNA Technologies →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 8ae50d76-d418-4477-af62-15e4b3e23e55 61 fields · synced 22 Oct 2026