Medical device licence · 95575 · Class 2
PC ECG
Yes: licensed in Canada
Licence status Issued (active); first licensed August 13, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95575
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 13, 2015
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTATION CABLE
- ELECTRODE ADAPTER
- EXERCISE ECG DONGLE
- PATIENT CABLE
- PC ECG
- RECEIVER
- SAMPLING BOX
- SMART ECG VIEWER DONGLE
- TRANSMITTER
- USB CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.