ApprovalTrail

Medical device licence · 100119 · Class 3

TCM5

Yes: licensed in Canada

Licence status Issued (active); first licensed December 7, 2017. It is in Health Canada’s list of active licences.
Licence number
100119
Licence holder
Radiometer Medical ApsBronshoj, Denmark
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 7, 2017
Devices covered
11

Devices on this licence

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

  • POWER CORD
  • TC SENSOR 54
  • TC SENSOR 84
  • TCM5
  • TCM5 ALICE INT. INTERFACE CABLE
  • TCM5 CALIBRATION GAS
  • TCM5 EMBLA EMBLETTA GOLD INTERFACE CABLE
  • TCM5 EMBLA INTERFACE CABLE
  • TCM5 EMBLA MDRIVE INTERFACE CABLE
  • TCM5 OPEN INTERFACE CABLE
  • TOSCA SENSOR 92

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