Medical device licence · 104793 · Class 3
COCHLEAR OSIA 2 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 18, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104793
- Licence holder
- Cochlear LimitedMacquarie Park, NSW, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 18, 2020
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COCHLEAR BONE BED INDICATOR
- COCHLEAR OSIA 2 SOUND PROCESSOR KIT
- COCHLEAR OSIA 3 CHARGER
- COCHLEAR OSIA 3 SOUND PROCESSOR
- COCHLEAR OSIA FITTING SOFTWARE 2
- COCHLEAR OSIA FITTING SOFTWARE 3
- COCHLEAR OSIA OSI200 IMPLANT
- COCHLEAR OSIA OSI200 IMPLANT TEMPLATE
- COCHLEAR OSIA SMART APP (ANDROID)
- COCHLEAR OSIA SMART APP (IOS)
- COCHLEAR STERILE NON-MAGNETIC PLUG
- COCHLEAR STERILE REPLACEMENT MAGNET
- PROGRAMMING CABLE CS45
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.