Medical device licence · 106984 · Class 2
WIRELESS 12-LEAD ECG SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 17, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106984
- Licence holder
- Mesi, Development Of Medical Devices, Ltd.Ljubljana, Slovenia
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 17, 2021
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 12-LEAD ECG DIAGNOSTIC MODULE
- 4 PORT MODULE CHARGING SYSTEM
- PATIENT CABLE - BANANA
- PATIENT CABLE ADAPTER
- SUCTION ELECTRODES
- SUCTION ELECTRODES KIT
- WIRELESS 12-LEAD ECG SYSTEM
- WIRELESS MEDICAL TABLET SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.