Identity
- Trade Name
- MEDRAD® Centargo CT Injector System EUDAMED
- Device Name
- MEDRAD® Centargo CT Injector System EUDAMED
- Model / Reference
- CENT-SYS-BAT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09345390001123 EUDAMED
- Basic UDI-DI
- 934539000TFCN-0099VY 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® Centargo CT Injector 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-0099VY | 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 897e94b3-8147-47ba-8035-90d3cf1086d2 61 fields · synced Jul 29, 2026