Medical device licence · 97109 · Class 3
BRIGHTMATTER GUIDE
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97109
- Licence holder
- Synaptive Medical Inc.Mississauga, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 16, 2016
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BRIGHTMATTER EXTERNAL DISPLAY
- BRIGHTMATTER GUIDE SOFTWARE
- BRIGHTMATTER POINTER TOOL
- BRIGHTMATTER TRACKING SYSTEM
- TRACKING ARRAY FOR BRAINPATH
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “brightmatter”. A notice may cover another product or only some lots: read it to see what it covers.
- BrightMatter Guide (2018-10-08)October 26, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.