ApprovalTrail

Medical device licence · 83334 · Class 3

SORIN C5 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 12, 2010. It is in Health Canada’s list of active licences.
Licence number
83334
Licence holder
Livanova Deutschland GmbhMunich, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 12, 2010
Devices covered
13

Devices on this licence

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

  • C5 SYSTEM
  • C5 SYSTEM - APC SENSOR MODULE (AIR PURGE CONTROL)
  • C5 SYSTEM - BATTERY/BATTERY DISCHARGER
  • C5 SYSTEM - CARDIOPLEGIA SENSOR MODULE
  • C5 SYSTEM - E/P PACK MODULES
  • C5 SYSTEM - PANEL
  • C5 SYSTEM - S5/C5 INTERFACE MODULE
  • C5 SYSTEM - S5/C5 SERIAL DATA OUTPUT MODULE
  • C5 SYSTEM - SENSOR MODULE 2 CHANNEL PRESSURE MONITOR
  • C5 SYSTEM - SENSOR MODULE 4 CHANNEL TEMPERATURE MONITOR
  • C5 SYSTEM - SENSOR MODULE FOR BUBBLE DETECTOR
  • C5 SYSTEM - SENSOR MODULE LEVEL MONITOR
  • C5 SYSTEM - TIMER MODULE

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