ApprovalTrail

Medical device licence · 107031 · Class 3

MAC 7 RESTING ECG ANALYSIS SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed November 30, 2021. It is in Health Canada’s list of active licences.
Licence number
107031
Licence holder
Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 30, 2021
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • MAC 7 RESTING ECG ANALYSIS SYSTEM
  • MAC 7 SW UPG KIT

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.