Medical device licence · 115050 · Class 3
CLEARPOINT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 16, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115050
- Licence holder
- Clearpoint Neuro, Inc.Carlsbad, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 16, 2026
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLEARPOINT 3.0
- CLEARPOINT NEURO WORKSTATION-WIN11
- SMARTFRAME ACCESSORY KIT
- SMARTFRAME EXPANDED ACCESSORY KIT
- SMARTFRAME PACK
- SMARTFRAME SCALP MOUNT BASE-REINFORCED
- SMARTFRAME XG PACK
- SMARTTIP MR DRILL KIT
- SMARTTIP MR HAND DRILL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.