Medical device licence · 95955 · Class 2
ISIRIS A STENT REMOVAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 19, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95955
- Licence holder
- Ambu ABallerupdk, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 19, 2015
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ISIRIS A
- ISIRIS MONITOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.