Medical device licence · 113968 · Class 3
VOLUSON PERFORMANCE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 15, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113968
- Licence holder
- Ge Ultrasound Korea, LtdSeongnam-Si, GD, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 15, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VOLUSON PERFORMANCE 16
- VOLUSON PERFORMANCE 18
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.