Identity
- Trade Name
- MEDRAD® Salient Contrast Injection System EUDAMED
- Device Name
- MEDRAD® Salient Contrast Injection System EUDAMED
- Model / Reference
- DC009S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09345390001345 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
MEDRAD® Salient Contrast Injection System by Imaxeon Pty 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 934539000TFCN-0102UU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Imaxeon Pty Ltd
- EUDAMED SRN
- AU-MF-000009702
- Authorised Representative
- Bayer Medical Care B.V. NL-AR-000000240
Sources (1)
- EUDAMED 2519cc49-c08f-418b-9049-1650375f3ca0 61 fields · synced Jun 18, 2026