ApprovalTrail

Medical device licence · 21303 · Class 2

HELIOS UNIVERSAL

Yes: licensed in Canada

Licence status Issued (active); first licensed June 8, 2000. It is in Health Canada’s list of active licences.
Licence number
21303
Licence holder
Caire Inc.Burnsville, MN, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 8, 2000
Devices covered
4

Devices on this licence

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

  • HELIOS MARATHON PORTABLE OXYGEN UNIT
  • HELIOS U36
  • HELIOS UNIVERSAL
  • HELIOS UNIVERSAL RESERVOIR

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