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PET/CT Image Analysis Software

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

Ref AI303006Model uAI PET Neurology

EMDN Z11020392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697419760PETNeurologyJQ 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
PET/CT Image Analysis Software
Model / Reference
uAI PET Neurology, AI303006
Primary DI / UDI-DI
06974197600678
Basic UDI-DI
697419760PETNeurologyJQ
EMDN Code
Z11020392 Integrated CT/pet systems - 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
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 3f6f0680-e159-4028-9dbd-5a4a1f316c70 61 fields · synced 23 Oct 2026