ApprovalTrail

Medical device licence · 101452 · Class 2

DREAMSTATION EXPERT

Yes: licensed in Canada

Licence status Issued with conditions; first licensed July 18, 2018. It is in Health Canada’s list of active licences.
Licence number
101452
Licence holder
Respironics Inc.Murrysville, PA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
July 18, 2018
Devices covered
11

Devices on this licence

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

  • DREAMSTATION CELLULAR MODEM
  • DREAMSTATION EXPERT
  • DREAMSTATION FLOW GENERATOR COVER
  • DREAMSTATION HUMIDIFIER
  • DREAMSTATION LINK MODULE
  • DREAMSTATION MICRO-FLEX PR12 TUBE STARTER PACK
  • DREAMSTATION NONIN SPO2 CABLE
  • DREAMSTATION TRAVEL KIT
  • DREAMSTATION WI-FI ACCESSORY
  • SHIELDED DC CORD - DREAMSTATION
  • SHIELDED DC CORD SYSTEM - DREAMSTATION

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