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Automated Chemiluminescent Immunoassay Analyzing System

by Sophonix Co., Ltd. China EUDAMED

Ref A02Model Aceso 80A EMDN W0201020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697418354A02NH Basic UDI-DIDate21 Jul 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Aceso 80A, A02
Primary DI / UDI-DI
06974183540292
Basic UDI-DI
697418354A02NH
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000021894
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Sophonix 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 9cb303ae-555a-49d5-9716-a6a263f2cc8b 61 fields · synced 22 Oct 2026