← Back to catalogue
MEDRAD® Salient Contrast Injection System MEDRAD® Vistron Plus Contrast Injecti…
EUDAMEDClass I (EU MDR)
Ref DC022Ref DC009DWRef DC009SWRef DC009SRef ZY6320
Identity
- Trade Name
- MEDRAD® Salient Contrast Injection System MEDRAD® Vistron Plus Contrast Injection System MEDRAD® Salient MEDRAD® Vistron Plus Heat Maintainer EUDAMEDMEDRAD® Salient Contrast Injection System EUDAMEDMEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System EUDAMED
- Device Name
- MEDRAD® Salient Contrast Injection System MEDRAD® Vistron Plus Contrast Injection System MEDRAD® Salient MEDRAD® Vistron Plus Heat Maintainer EUDAMEDMEDRAD® Salient Contrast Injection System EUDAMEDMEDRAD® Salient MEDRAD® Vistron Plus Sterile Disposables EUDAMED
- Model / Reference
- DC022 EUDAMEDDC009DW EUDAMEDDC009SW EUDAMEDDC009S EUDAMEDZY6320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09345390002779 EUDAMED09345390003394 EUDAMED09345390003318 EUDAMED09345390003035 EUDAMED09345390001352 EUDAMED09345390003370 EUDAMED09345390003028 EUDAMED09345390000751 EUDAMED09345390000492 EUDAMED
- Basic UDI-DI
- 934539000TFCN-0102IC5 EUDAMED934539000TFCN-0102UU EUDAMED934539000TFCN-0103UW EUDAMED
- EMDN Code
- A030105 FLUIDS HEATING SYSTEMS EUDAMEDZ11039013 ANGIOGRAPHIC INJECTORS EUDAMEDA03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDEstonia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
No
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MEDRAD® Salient Contrast Injection System MEDRAD® Vistron Plus Contrast Injecti… by Imaxeon Pty Ltd — Class I — MDR — listed in EUDAMED
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-0102IC5 | Class I | 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 (9)
- EUDAMED d1014898-ec2a-4236-8bbe-07bf72c39e12 61 fields · synced Aug 1, 2026
- EUDAMED 0a28d4d7-2f47-48d5-8e89-6802a4a72896 61 fields · synced Jun 18, 2026
- EUDAMED e8299853-f03a-4192-8b57-f8fec2cad416 61 fields · synced Jul 11, 2026
- EUDAMED 64f7d179-bd96-4970-b400-72bb2ae45ec8 61 fields · synced Jul 12, 2026
- EUDAMED 1e43d474-6806-4836-9469-e2daa9ffb715 61 fields · synced Jul 13, 2026
- EUDAMED 186c2011-066c-445f-9cdb-f6c7abc9ea2d 61 fields · synced Jul 14, 2026
- EUDAMED 294fd314-3566-48a6-b730-80e58335400e 61 fields · synced Jul 15, 2026
- EUDAMED 63627cc9-cf95-42b1-aa63-bd23dbd8e328 61 fields · synced Jul 20, 2026
- EUDAMED 8cbae975-9a5d-4073-8ab2-a35d21547f07 61 fields · synced Aug 1, 2026