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AA01

by Otsuka Electronics Co., Ltd. Japan EUDAMED

Ref 04987274142079Model AA01

EMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987274W0201010101A01EW Basic UDI-DIDate31 Aug 2022RegisteredStatusActive

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
Discrete Clinical Chemistry Analyzer AA01
Model / Reference
AA01, 04987274142079
Primary DI / UDI-DI
04987274142079
Basic UDI-DI
4987274W0201010101A01EW
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000001943
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Otsuka Electronics 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 6f1b67d9-8dbc-46ea-aa64-a90038bac3e7 61 fields · synced 22 Oct 2026