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Agnitio BioIC Analyzer

by Agnitio Science &Technology, Inc. Taiwan EUDAMED

Ref BA-G2012 seriesModel BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series

EMDN W0201020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471989299Analyzer8A Basic UDI-DIDate19 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
BA-G2000 series/BA-G2012 series/BA400 series/ BA1200 series/BA2400 series, BA-G2012 series
Primary DI / UDI-DI
04719892999021
Basic UDI-DI
471989299Analyzer8A
Direct Marketing DI
04719892999021
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
TW-MF-000040942
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Agnitio Science &Technology, Inc.

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 ab86c69f-20c4-4002-bc4e-1afba00d55a4 61 fields · synced 25 Oct 2026