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GenoXtract fleXT

by Hamilton Bonaduz AG United States EUDAMED

Ref 806681

EMDN W02060199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number07630032680668196 Basic UDI-DIDate24 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
806681
Primary DI / UDI-DI
07630032629127
Basic UDI-DI
07630032680668196, 76300326806681MY
Direct Marketing DI
07630032629127
EMDN Code
W02060199 Robotic sample processing systems - other
Device Class
Class A
Market of Registration
Spain
Austria

Manufacturer details

EUDAMED SRN
CH-MF-000013585
Authorised representative
Johner Medical GmbH DE-AR-000011832

Other devices from Hamilton Bonaduz AG

See all devices from Hamilton Bonaduz AG →

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • New Device YesEUDAMEDNoEUDAMED
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (2)

  • EUDAMED 7f2a5b3f-2ac1-43a2-a7af-81dd0e27fc24 61 fields · synced 22 Oct 2026
  • EUDAMED fb4875b9-ac38-4792-ad8d-e2f9d6c251bd 61 fields · synced 16 Jul 2026