Medical device licence · 95396 · Class 2
DREAMSTATION CPAP
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95396
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 30, 2015
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DREAMSTATION CELLULAR MODEM
- DREAMSTATION CPAP
- 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
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “dreamstation”. A notice may cover another product or only some lots: read it to see what it covers.
- Dreamstation Cellular ModemJune 5, 2017 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.