Medical device licence · 95991 · Class 4
PENUMBRA SMART COIL
Yes: licensed in Canada
Licence status Issued (active); first licensed October 29, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95991
- Licence holder
- Penumbra Inc.Alameda, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 29, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PENUMBRA SMART COIL DETACHMENT HANDLE
- SMART COIL EXTRA SOFT
- SMART COIL SMART PLUS STANDARD
- SMART COIL SOFT
- SMART COIL STANDARD
- SMART COIL WAVE EXTRA SOFT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.