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Ca-800

by Furuno Electric Co., Ltd. Japan EUDAMED

Ref CA000001551

EMDN W0201010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0456016CA-800-NOISECD 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 22 Oct 2026

Device Name
Clinical Chemistry Analyzer CA-800 without ISE
Model / Reference
CA000001551
Primary DI / UDI-DI
04560161906871
Basic UDI-DI
0456016CA-800-NOISECD
Direct Marketing DI
04560161906871
EMDN Code
W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
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 a5b3095b-b4b7-41cc-8e2e-2c7d4d4058bf 61 fields · synced 22 Oct 2026