Medical device licence · 76100 · Class 2
EMPOWERMR INJECTOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 28, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76100
- Licence holder
- Bracco Injeneering S.A.Lausanne, SZ, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 28, 2008
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMPOWER 10 USB KEY FOR ONYX 17
- EMPOWERMR INJECTOR SYSTEM - ELECTRO-HYDRAULIC INTERCONNECT
- EMPOWERMR INJECTOR SYSTEM - HYDRAULIC CONTROLLER WITH LINE CORD
- EMPOWERMR INJECTOR SYSTEM - INJECTOR HEAD
- EMPOWERMR INJECTOR SYSTEM - MAIN UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.