Medical device licence · 60031 · Class 2
MEDGEM
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed July 9, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60031
- Licence holder
- Healthetech Inc.Golden, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 9, 2002
- Ended
- February 16, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MEDGEM - KIT
- MEDGEM - MASK
- MEDGEM - MOUTHPIECE
- MEDGEM - NOSE CLIP
- MEDGEM - SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.