Medical device licence · 106876 · Class 2
WGS-100
Yes: licensed in Canada
Licence status Issued (active); first licensed October 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106876
- Licence holder
- Ivy Biomedical Systems Inc.Branford, CT, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 26, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEHC WGS-100 BASE STATION
- GEHC WGS-100 TRANSMITTER
- MRI ECG PATIENT CABLE
- MRI PPG PATIENT CABLE
- WGS-100 BASE STATION
- WGS-100 CHARGER
- WGS-100 TRASMITTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.