Medical device licence · 95323 · Class 2
ECG CABLE
Yes: licensed in Canada
Licence status Issued (active); first licensed June 19, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95323
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 19, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- D-SUB UNIVERSAL INTERFACE ECG CABLES
- DE15 ELECTROCARDIOGRAPH LEAD CABLES
- DX12 ECG CABLES
- ECG CABLE
- ECG LIMB CABLES
- ECG TRUNK CABLES
- HOLTER LEAD CABLES
- INTEGRATED ECG LEAD CABLES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.