ApprovalTrail

Medical device licence · 108759 · Class 2

MASIMO SOFTFLOW

Yes: licensed in Canada

Licence status Issued (active); first licensed January 11, 2023. It is in Health Canada’s list of active licences.
Licence number
108759
Licence holder
Tni Medical AgWürzburg, 09, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
January 11, 2023
Devices covered
22

Devices on this licence

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

  • MASIMO 7 DAYS CLINIC HYGIENCE SET
  • MASIMO SOFTFLOW
  • MASIMO SOFTFLOW AIR BRIDGE, HUMIDIFIER CLINIC
  • MASIMO SOFTFLOW APPLICATOR MODULE JUNIOR, SOFTFLOW JUNIOR
  • MASIMO SOFTFLOW HUMIDIFIER CLINIC HYGIENE SET
  • MASIMO SOFTFLOW HUMIDIFIER HOMECARE
  • MASIMO SOFTFLOW INNOTUBE SOFTFLOW
  • MASIMO SOFTFLOW JUNIOR SET INTERNATIONAL CLINIC
  • MASIMO SOFTFLOW JUNIOR SET INTERNATIONAL HOMECARE
  • MASIMO SOFTFLOW SET INTERNATIONAL, CLINIC
  • MASIMO SOFTFLOW SET INTERNATIONAL, HOMECARE
  • MASIMO SOFTFLOW TEMPERATURE MEASURING ELEMENT, INNOTUBE SOFTFLOW
  • MASIMO SOFTFLOW, APPLICATOR CLINIC, TRACHEAL-INTERFERENCE
  • MASIMO SOFTFLOW, APPLICATOR HOMECARE STANDARD-PLUS
  • MASIMO SOFTFLOW, APPLICATOR HOMECARE, TRACHEAL-INTERFERENCE
  • MASIMO SOFTFLOW, APPLICATOR LARGE, CLINIC
  • MASIMO SOFTFLOW, APPLICATOR LARGE, HOMECARE
  • MASIMO SOFTFLOW, APPLICATOR SMALL, CLINIC
  • MASIMO SOFTFLOW, APPLICATOR SMALL, HOMECARE
  • MASIMO SOFTFLOW, APPLICATOR STANDARD, CLINIC
  • MASIMO SOFTFLOW, APPLICATOR STANDARD, HOMECARE
  • MASIMO SOFTFLOW, APPLICATOR STANDARD-PLUS CLINIC

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