Medical device licence · 109900 · Class 3
REVOLUTION APEX SELECT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109900
- Licence holder
- Ge Hangwei Medical Systems Co. Ltd.Beijing, China
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- August 14, 2023
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REVOLUTION APEX SELECT
- REVOLUTION APEX SELECT WITH ELITE EDITION
- REVOLUTION APEX SELECT WITH PLUS EDITION
- REVOLUTION VIBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.