Medical device licence · 97810 · Class 4
EDWARDS INTUITY ELITE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97810
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- October 13, 2016
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EDWARDS INUITY ELITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.