← Back to catalogue
MEDRAD® Salient Contrast Injection System
EUDAMEDClass IIb (EU MDR)
Ref DC009SW
Identity
- Trade Name
- MEDRAD® Salient Contrast Injection System EUDAMED
- Device Name
- MEDRAD® Salient Contrast Injection System EUDAMED
- Model / Reference
- DC009SW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09345390000744 EUDAMED
- Basic UDI-DI
- 934539000TFCN-0102UU EUDAMED
- EMDN Code
- Z11039013 ANGIOGRAPHIC INJECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The MEDRAD Salient Contrast Injection System is a medical device designed for the administration of contrast agents in radiology, providing high-quality images with minimal radiation exposure. With its advanced technology and user-friendly interface, this system enables healthcare professionals to deliver precise and effective treatments.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 934539000TFCN-0102UU | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imaxeon Pty Ltd
- EUDAMED SRN
- AU-MF-000009702
- Authorised Representative
- Bayer Medical Care B.V. NL-AR-000000240
Sources (1)
- EUDAMED e26e238a-b265-47ab-8959-89bd5eb28cee 61 fields · synced Jun 28, 2026