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Ultrasonic Endoscope EG-580UT

by FUJIFILM Corporation EUDAMED

Active European Union

Ref 04547410346374

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4547410201000000000011557 Basic UDI-DIDate23 Jul 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  • Withdrawn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

Device Name
Ultrasonic Endoscope (Upper Gastrointestinal Endoscope) 3
Model / Reference
04547410346374
Primary DI / UDI-DI
04547410346374
Basic UDI-DI
4547410201000000000011557
Direct Marketing DI
04547410346374
EMDN Code
Z12020503 Echo–gastroscopes
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

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Properties

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