Medical device licence · 105878 · Class 2
TR SERIES
Yes: licensed in Canada
Licence status Issued (active); first licensed February 22, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105878
- Licence holder
- The Prometheus GroupDover, NH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 22, 2021
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER FOR DISPOSABLE LEAD WIRE ELECTRODES
- DISPOSABLE LEAD WIRE ELECTRODES
- EASYTRODE PREGELLED ELECTRODES
- ELECTRODE LEAD WIRE SET
- PATHWAY ADAPTER
- PATHWAY ELECTRODES
- PATHWAY PREAMPLIFIER
- PATHWAY TR SERIES
- SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.