Medical device licence · 76826 · Class 2
HANDLES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 14, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76826
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 14, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HANDLE
- HANDLE, FLEXIBLE, FOR HEART VALVES
- STAINLESS STEEL HANDLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.