MEDRAD® Salient Contrast Injection System
by Imaxeon Pty Ltd Australia EUDAMED
Ref DC009DW EMDN Z11039013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number934539000TFCN-0102UU | Date14 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- DC009DW
- Primary DI / UDI-DI
- 09345390003394, 09345390003318, 09345390003035, 09345390000751, 09345390001376
- Basic UDI-DI
- 934539000TFCN-0102UU
- EMDN Code
- Z11039013 Angiographic injectors
- Device Class
- Class IIb
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- AU-MF-000009702
- Authorised representative
- Bayer Medical Care B.V. NL-AR-000000240
Other devices from Imaxeon Pty Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (5)
- EUDAMED 0a28d4d7-2f47-48d5-8e89-6802a4a72896
- EUDAMED 09345390003318|934539000TFCN-0102UU
- EUDAMED 09345390003035|934539000TFCN-0102UU
- EUDAMED 09345390000751|934539000TFCN-0102UU
- EUDAMED 09345390001376|934539000TFCN-0102UU