ApprovalTrail

Medical device licence · 64678 · Class 2

INFANT FLOW (CPAP) SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed June 7, 2004; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
64678
Licence holder
Vyaire Medical OyHelsinki, Finland
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
June 7, 2004
Ended
December 9, 2025
Devices covered
10

Devices on this licence

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

  • INFANT FLOW ABDOMINAL RESPIRATORY SENSOR
  • INFANT FLOW CPAP SYSTEM - BONNET
  • INFANT FLOW CPAP SYSTEM - CIRCUITS
  • INFANT FLOW CPAP SYSTEM - CIRCUITS W/GENERATOR
  • INFANT FLOW CPAP SYSTEM - INFANT FLOW GENERATORS
  • INFANT FLOW CPAP SYSTEM - INFANT FLOW P. DRIVER
  • INFANT FLOW CPAP SYSTEM - MASK
  • INFANT FLOW CPAP SYSTEM -PRONGS
  • INFANT FLOW EXTENSION TUBING
  • INFANT FLOW SILENCER/BACTERIA FILTER

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