MEDRAD® Centargo CT Injection System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Centargo CT Injector System EUDAMEDMEDRAD® Centargo CT Injection System FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- MEDRAD® Centargo CT Injector System EUDAMEDMEDRAD® Centargo CT Injection System FDA UDI
- Model / Reference
- CENT-SYS-BAT EUDAMEDFDA UDI
- Description
- MEDRAD® Centargo CT Injection System FDA UDI
Identifiers
- Catalog Number
- CENT-SYS-BAT FDA UDI
- Primary DI / UDI-DI
- 09345390002137 EUDAMED09345390003349 FDA UDI
- Basic UDI-DI
- 934539000TFCN-0099VY EUDAMED
- FDA Product Code
- IZQ FDA UDIDXT FDA UDI
- EMDN Code
- Z11039013 ANGIOGRAPHIC INJECTORS EUDAMED
- GMDN Term
- CT contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: CT contrast medium injection system, line-powered, mobile
MEDRAD® Centargo CT Injection System by Imaxeon Pty Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Imaxeon Pty Ltd
Sources (2)
- FDA UDI ab0b1193-8061-4abc-b1a4-783757125272 37 fields · synced Jul 9, 2026
- EUDAMED 972357cc-000d-49d3-b822-52504cba8e91 61 fields · synced Jul 9, 2026