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Imagemate CT-Pro Injection System

EUDAMED

Class IIb (EU MDR)

Ref ImageMate CT-pro MRef ImageMate CT-pro ERef ImageMate CT-pro S

by Suzhou Hengrui Hongyuan Medical Co., Ltd.

Identity

Trade Name
Imagemate CT-Pro Injection System EUDAMED
Device Name
Imagemate CT-Pro Injection System EUDAMED
Model / Reference
ImageMate CT-pro M EUDAMED
ImageMate CT-pro E EUDAMED
ImageMate CT-pro S EUDAMED

Identifiers

Primary DI / UDI-DI
06973955107398 EUDAMED
06973955107411 EUDAMED
06973955107404 EUDAMED
Basic UDI-DI
697395510CICE1JP EUDAMED
697395510CICE2JR EUDAMED
697395510CICEMT EUDAMED
Direct Marketing DI
06973955107398 EUDAMED
06973955107411 EUDAMED
06973955107404 EUDAMED
EMDN Code
Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Poland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMEDEUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Imagemate CT-Pro Injection System by Suzhou Hengrui Hongyuan Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Suzhou Hengrui Hongyuan Medical Co., Ltd.
EUDAMED SRN
CN-MF-000044883
Authorised Representative
PureCE B.V. NL-AR-000006069

Sources (3)

  • EUDAMED 504b4585-4d65-441e-89c1-c0cf74a2660e 61 fields · synced Oct 6, 2026
  • EUDAMED ee636d3e-f49b-4b87-898f-3fdfdd730f30 61 fields · synced May 17, 2026
  • EUDAMED 3d0d150d-25e5-476c-a145-1fa8c884e2dd 61 fields · synced May 18, 2026