Medical device licence · 112827 · Class 2
OKTI
Yes: licensed in Canada
Licence status Issued (active); first licensed March 6, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112827
- Licence holder
- Compumedics LimitedAbbotsford, VIC, Australia
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 6, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OKTI AMBULATORY EEG RECORDER ONLY
- OKTI CHANNEL ACQUISITION MODULE
- OKTI CHANNEL AMBULATORY EEG SYSTEM MODULE
- OKTI RECORDER BASE UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.