Medical device licence · 616 · Class 2
SOMNOPLASTY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 616
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 7, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOMNOPLASTY SYSTEM
- SOMNOPLASTY SYSTEM - CABLES
- SOMNOPLASTY SYSTEM - POWER CORD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.