Medical device licence · 106894 · Class 2
ECG ANALYSIS SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 29, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106894
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 29, 2021
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ECG ANALYSIS SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.