ApprovalTrail

Medical device licence · 113827 · Class 2

CLEARO

Yes: licensed in Canada

Licence status Issued (active); first licensed August 19, 2025. It is in Health Canada’s list of active licences.
Licence number
113827
Licence holder
Breas Medical AbMolnlycke, Sweden
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 19, 2025
Devices covered
11

Devices on this licence

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

  • CLEARO
  • CLEARO AC MAINS CABLE (US)
  • CLEARO BACTERIAL FILTER
  • CLEARO COARSE AIR INLET FILTER, GREY
  • CLEARO FINE AIR INLET FILTER, WHITE
  • CLEARO HAND CONTROL
  • CLEARO INTERNAL BATTERY LITHIUM-ION 8INR19/66
  • CLEARO IPPB CIRCUITS CA
  • CLEARO OXYGEN CONNECTOR
  • PATIENT CIRCUIT AMERICAS
  • SPO2 MODULE

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