Medical device licence · 109975 · Class 3
UNIVERSAL SMARTECG
Yes: licensed in Canada
Licence status Issued (active); first licensed September 5, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109975
- Licence holder
- Vectracor, Inc.Totowa, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 5, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADHESIVE SOLID GEL RESTING EKG TAB ELECTRODES
- OFFICE MEDIC
- UNIVERSAL SMARTECG
- VECTRAPLEXECG
- WET GEL MONITORING ELECTRODES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.