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Mammo Image Analysis Software

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

Ref AI303008Model uAI Clinical Portal Mammo

EMDN Z11030292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697419760CPortalMammo7R 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 22 Oct 2026

Device Name
Mammo Image Analysis Software
Model / Reference
uAI Clinical Portal Mammo, AI303008
Primary DI / UDI-DI
06974197600692
Basic UDI-DI
697419760CPortalMammo7R
EMDN Code
Z11030292 Mammography 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
  • 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 ec437c90-dd9a-443e-8963-20a24e9c96ef 61 fields · synced 22 Oct 2026