Medical device licence · 65869 · Class 2
COMFORTSAMPLER
Yes: licensed in Canada
Licence status Issued (active); first licensed September 21, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65869
- Licence holder
- Opti Medical Systems, Inc.Roswell, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- September 21, 2004
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMFORTSAMPLER KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.