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Field Verification Kit

by Hamilton Bonaduz AG United States EUDAMED

Ref 911144

EMDN W0580

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0763003269111447U Basic UDI-DIDate18 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
FV2 IVD Software
Model / Reference
911144
Primary DI / UDI-DI
07630032638419
Basic UDI-DI
0763003269111447U, 76300326911144LN
Direct Marketing DI
07630032638419
EMDN Code
W0580 IVD general use consumables devices - other accessories
Device Class
Class A
Special Device Type
Software
Market of Registration
Germany
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
Other properties (11)
  • 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
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 967f5aab-0a56-47da-972c-a86adb928769 61 fields · synced 23 Oct 2026
  • EUDAMED 07630032638419|76300326911144LN 61 fields · synced 23 Oct 2026