ApprovalTrail

Medical device licence · 88006 · Class 3

SEDLINE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 9, 2012. It is in Health Canada’s list of active licences.
Licence number
88006
Licence holder
Masimo CorporationIrvine, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 9, 2012
Devices covered
6

Devices on this licence

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

  • SEDLINE SYSTEM - BIOMED KIT
  • SEDLINE SYSTEM - EEG SENSOR
  • SEDLINE SYSTEM - MONITOR
  • SEDLINE SYSTEM - PATIENT CABLE
  • SEDLINE SYSTEM - PATIENT CABLE TEST KIT
  • SEDLINE SYSTEM - PATIENT MODULE

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