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PET/CT Computer-Aided Diagnostic Software

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

Ref AI303002Model uAI MI Oncology

EMDN Z11020392

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697419760MIOncologyND Basic UDI-DIDate20 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PET/CT Computer-Aided Diagnostic Software
Model / Reference
uAI MI Oncology, AI303002
Primary DI / UDI-DI
06974197600371
Basic UDI-DI
697419760MIOncologyND
EMDN Code
Z11020392 Integrated CT/pet systems - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Malta

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 bef9055c-ddd9-4bbf-abfc-04e403d0b06e 61 fields · synced 22 Oct 2026