ApprovalTrail

Medical device licence · 109010 · Class 2

UNITRON FITTING SOFTWARE

Yes: licensed in Canada

Licence status Issued (active); first licensed March 2, 2023. It is in Health Canada’s list of active licences.
Licence number
109010
Licence holder
Sonova AgStafa, ZH, Switzerland
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 2, 2023
Devices covered
3

Devices on this licence

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

  • AURA:FIT
  • AURA:FIT AUDIONOVA
  • UNITRON TRUEFIT

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