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Imagemate CT-Pro Injection System

by Suzhou Hengrui Hongyuan Medical Co., Ltd. China EUDAMED

Ref ImageMate CT-pro S EMDN Z11039014

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697395510CICEMT Basic UDI-DIDate2 Jan 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  • Withdrawn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 24 Oct 2026

Model / Reference
ImageMate CT-pro S
Primary DI / UDI-DI
06973955107404
Basic UDI-DI
697395510CICEMT
Direct Marketing DI
06973955107404
EMDN Code
Z11039014 Multiple contrast agent injectors
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000044883
Authorised representative
PureCE B.V. NL-AR-000006069

Other devices from Suzhou Hengrui Hongyuan Medical Co., Ltd.

See all devices from Suzhou Hengrui Hongyuan Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 3d0d150d-25e5-476c-a145-1fa8c884e2dd 61 fields · synced 24 Oct 2026