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Ca-400

by Furuno Electric Co., Ltd. Japan EUDAMED

Ref CA000001475

EMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0456016CA-400-ISEN5 Basic UDI-DIDate13 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

Device Name
Clinical Chemistry Analyzer CA-400 with ISE
Model / Reference
CA000001475
Primary DI / UDI-DI
04560161906840
Basic UDI-DI
0456016CA-400-ISEN5
Direct Marketing DI
04560161906840
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
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
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 5fc5852f-7908-40f7-b102-bb42e1d15b84 61 fields · synced 23 Oct 2026