Medical device licence · 108531 · Class 2
ELECTROCARDIOGRAPH
Yes: licensed in Canada
Licence status Issued (active); first licensed November 9, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108531
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 9, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONNECTION CABLE
- ECG CABLE
- ELECTROCARDIOGRAPH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.