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Cardiac CT Image Processing Software

by SenseCare Smart Health Technology Co., Ltd. China EUDAMED

Ref SenseCare-Cardiac Lite EMDN Z11030692

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697577533012PR Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cardiac CT Image Processing Software
Model / Reference
SenseCare-Cardiac Lite
Primary DI / UDI-DI
06975775330123
Basic UDI-DI
697577533012PR
Direct Marketing DI
06975775330123
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000016662
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from SenseCare Smart Health Technology Co., Ltd.

See all devices from SenseCare Smart Health Technology 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 3bd42604-0768-4846-94ce-c3439526760f 61 fields · synced 22 Oct 2026