Medical device licence · 97185 · Class 2
HALO
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed June 25, 2016; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 97185
- Licence holder
- Heart Sync, Inc. Medical Devices, Inc.Ann Arbor, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 25, 2016
- Ended
- July 29, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HALO SEALS
- HALO TRAUMA DRESSING XL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.