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Lesion Visualizer

by CANFIELD SCIENTIFIC Inc United States EUDAMED

Ref 54000 EMDN Z12040192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number008600106181LVDR Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
54000
Primary DI / UDI-DI
00860010618110
Basic UDI-DI
008600106181LVDR
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000042029
Authorised representative
CANFIELD SCIENTIFIC SRL IT-AR-000040560

Other devices from CANFIELD SCIENTIFIC Inc

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 1ffb9a75-6f72-4f56-ac35-d4f006558270 61 fields · synced 24 Oct 2026