ApprovalTrail

Medical device licence · 103542 · Class 2

GEMS SIRONA

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 4, 2019; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
103542
Licence holder
Cardiocomm Solutions, Inc.Toronto, ON, Canada
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
September 4, 2019
Ended
December 9, 2025
Devices covered
12

Devices on this licence

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

  • 2 WIRE 1-CHANNEL EVENT CABLE
  • 3 WIRE 2-CHANNEL EVENT CABLE
  • 5 WIRE 3-CHANNEL HOLTER CABLE
  • 7 WIRE 3-CHANNEL HOLTER CABLE
  • AC CHARGER
  • GEMS SIRONA
  • GEMS SIRONA VIEWER - ANDROID
  • GEMS SIRONA VIEWER - PC
  • PATCH
  • PATCH ADAPTER ACCESSORY
  • POST EVENT ADAPTER ACCESSORY
  • USB CHARGING/DOWNLOAD CABLE

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