ApprovalTrail

Medical device licence · 106799 · Class 3

IN-LINE SENSOR MODULES

Yes: licensed in Canada

Licence status Issued (active); first licensed October 8, 2021. It is in Health Canada’s list of active licences.
Licence number
106799
Licence holder
Livanova Deutschland GmbhMunich, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 8, 2021
Devices covered
8

Devices on this licence

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

  • B-CAPTA ARTERIAL CUVETTE FOR PO2 AND TEMPERATURE
  • B-CAPTA ARTERIAL HOLDER
  • B-CAPTA ARTERIAL SENSOR
  • B-CAPTA SENSOR MODULE
  • B-CAPTA VENOUS CUVETTE FOR SO2, HCT/HB AND TEMPERATURE
  • B-CAPTA VENOUS HOLDER
  • B-CAPTA VENOUS SENSOR
  • ESSENZ ILBM SENSOR MODULE

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