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Vivix-D

by Vieworks Co., Ltd. South Korea EUDAMED

Ref FXDD-1212GA EMDN Z11031180

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809394330449 Basic UDI-DIDate12 Jul 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
FXDD-1212GA
Primary DI / UDI-DI
08809394330449
Basic UDI-DI
B-08809394330449
EMDN Code
Z11031180 Systems for direct digital radiology (dr) - hardware accessories
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000020017
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Vieworks Co., Ltd.

See all devices from Vieworks Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 33d521ee-757f-4069-967f-d055eabfb3c2 61 fields · synced 24 Oct 2026