ApprovalTrail

Medical device licence · 114259 · Class 3

ONE LAMBDA DEVYSER CHIMERISM

Yes: licensed in Canada

Licence status Issued (active); first licensed October 31, 2025. It is in Health Canada’s list of active licences.
Licence number
114259
Licence holder
Devyser AbArsta, Sweden
Risk class
Class III (moderate to high risk)
Licence type
Test Kit
First licensed
October 31, 2025
Devices covered
4

Devices on this licence

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

  • ADVYSER CHIMERISM
  • DEVYSER INDEX PLATE LB-A
  • DEVYSER LIBRARY CLEAN
  • ONE LAMBDA DEVYSER CHIMERISM

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