Medical device licence · 86177 · Class 4
SYNCARDIA EXTERNAL DRIVERS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 25, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86177
- Licence holder
- Syncardia Systems, LlcTucson, AZ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- May 25, 2011
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPANION 2 DRIVER SYSTEM
- FREEDOM DISCHARGE KIT
- FREEDOM DRIVER SYSTEM
- FREEDOM STANDBY KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.