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ISE Cleaner

by Furuno Electric Co., Ltd. Japan EUDAMED

Ref 003B4034800

EMDN V0799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0456016H-ISE_CleanerEV Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
003B4034800
Primary DI / UDI-DI
04560161906802
Basic UDI-DI
0456016H-ISE_CleanerEV
Direct Marketing DI
04560161906802
EMDN Code
V0799 Products for cleaning medical devices not included in other classes - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
JP-MF-000026828
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Furuno Electric Co., Ltd.

See all devices from Furuno Electric Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED bb5e0468-de66-49c2-8392-4a60f633cd35 61 fields · synced 23 Oct 2026