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Carotid CT Image Intelligent 3D-reconstruction Software

by SenseCare Smart Health Technology Co., Ltd.

Ref SenseCare-Carotid 3D

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697577533019Q7 Basic UDI-DI 06975775330192UDI-DIDate13 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Carotid CT Image Intelligent 3D-reconstruction Software
Model / Reference
SenseCare-Carotid 3D
Primary DI / UDI-DI
06975775330192
Basic UDI-DI
697577533019Q7
Direct Marketing DI
06975775330192
EMDN Code
Z11030692 Computed tomographs (CT) - medical device software
Device Class
Class I
Special Device Type
Software
EU 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

  • 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