Medical device licence · 68536 · Class 3
SONABLATE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 1, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68536
- Licence holder
- Focus Surgery Inc.Indianapolis, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 1, 2005
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BOLUS GUIDE
- SONABLATE INSERTION PACK
- SONABLATE PROBE
- SONACHILL
- SONASOURCE CONSOLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.