Medical device licence · 110843 · Class 2
PRECISE
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed February 19, 2024; ended June 12, 2026. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 110843
- Licence holder
- Arteriocyte Medical Systems, Inc.Hopkinton, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- February 19, 2024
- Ended
- June 12, 2026
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRECISE DIAMOND - 120ML LP KIT
- PRECISE DIAMOND - 60ML LP KIT
- PRECISE SAPPHIRE - 120ML LR KIT
- PRECISE SAPPHIRE - 60ML LR KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.