Medical device licence · 110050 · Class 3
COCHLEAR OSIA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 18, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110050
- Licence holder
- Cochlear LimitedMacquarie Park, NSW, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 18, 2023
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COCHLEAR BONE BED INDICATOR
- COCHLEAR MAGNET CASSETTE
- COCHLEAR NON-MAGNETIC CASSETTE
- COCHLEAR OSIA 2(I) SOUND PROCESSOR KIT
- COCHLEAR OSIA 3 CHARGER
- COCHLEAR OSIA 3(I) SOUND PROCESSOR
- COCHLEAR OSIA FITTING SOFTWARE 2
- COCHLEAR OSIA FITTING SOFTWARE 3
- COCHLEAR OSIA OSI200 IMPLANT TEMPLATE
- COCHLEAR OSIA OSI300 IMPLANT
- COCHLEAR OSIA SMART APP (ANDROID)
- COCHLEAR OSIA SMART APP (IOS)
- PROGRAMMING CABLE CS45
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.