Medical device licence · 65544 · Class 2
SOMTE PATIENT RECORDING SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed August 19, 2004; ended December 7, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 65544
- Licence holder
- Compumedics LimitedAbbotsford, VIC, Australia
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- August 19, 2004
- Ended
- December 7, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOMTE ANALYSIS SOFTWARE PACK
- SOMTE ELECTRODES AND SENSORS
- SOMTE PATIENT INPUT BOX
- SOMTE RECORDER
- SOMTE RECORDING SYSTEM W/SOFTWARE
- SOMTE SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.