Medical device licence · 76858 · Class 2
ELECTROCARDIOGRAPH
Yes: licensed in Canada
Licence status Issued (active); first licensed April 17, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76858
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 17, 2008
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER
- ECG CABLE
- ELECTROCARDIOGRAPH
- RECHARGEABLE LI-ION BATTERY
- SE-601 SERIES 6-CHANNEL ELECTROCARDIOGRAPH
- SMART ECG (SE) SERIES-12 CHANEL ELECTROCARDIOGRAPH
- SMART ECG (SE) SERIES-3 CHANEL ELECTROCARDIOGRAPH
- SMART ECG (SE) SERIES-6 CHANEL ELECTROCARDIOGRAPH
- SMART ECG (SE) SERIES-SINGLE CHANEL ELECTROCARDIOGRAPH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.