ApprovalTrail

Medical device licence · 85942 · Class 3

ABL90 FLEX

Yes: licensed in Canada

Licence status Issued (active); first licensed May 2, 2011. It is in Health Canada’s list of active licences.
Licence number
85942
Licence holder
Radiometer Medical ApsBronshoj, Denmark
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
May 2, 2011
Devices covered
5

Devices on this licence

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

  • ABL90 FLEX - ANALYZER
  • ABL90 FLEX - CALIBRATION SOLUTIONS
  • ABL90 FLEX - SENSOR CASSETTE OXI+QC
  • ABL90 FLEX - SOLUTION PACK
  • ABL90 FLEX PLUS

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