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CT Image Analysis Software

by Shanghai United Imaging Intelligence Co., Ltd. China EUDAMED

Ref AI303005Model uAI Clinical Portal CT Series II

EMDN Z11030692

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697419760CPortalCT2T5 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
CT Image Analysis Software
Model / Reference
uAI Clinical Portal CT Series II, AI303005
Primary DI / UDI-DI
06974197600661
Basic UDI-DI
697419760CPortalCT2T5
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000035682
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shanghai United Imaging Intelligence Co., Ltd.

See all devices from Shanghai United Imaging Intelligence Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a18b7991-793d-463e-91e5-6ff6c5af038f 61 fields · synced 23 Oct 2026