Medical device licence · 104201 · Class 2
OPTOMED AURORA
Yes: licensed in Canada
Licence status Issued (active); first licensed January 22, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104201
- Licence holder
- Optomed OyjOulu, Finland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 22, 2020
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTOMED AURORA ANTERIOR MODULE
- OPTOMED AURORA CAMERA
- OPTOMED AURORA CHARGING STATION
- OPTOMED AURORA RETINAL MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.