Medical device licence · 105194 · Class 2
EMYO SERIES
Yes: licensed in Canada
Licence status Issued (active); first licensed September 23, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105194
- Licence holder
- The Prometheus GroupDover, NH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 23, 2020
- 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
- EMYO SERIES
- PATHWAY ADAPTER
- PATHWAY ELECTRODES
- PATHWAY PREAMPLIFIER
- SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.