Medical device licence · 98298 · Class 3
HIRESOLUTION BIONIC EAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 23, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98298
- Licence holder
- Advanced Bionics, LlcSylmar, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 23, 2016
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HIFOCUS ELECTRODE FORCEPS KIT
- HIFOCUS MS ELECTRODE INSERTION TOOL
- HIFOCUS MS ELECTRODE INSERTION TOOL KIT
- HIFOCUS SLIMJ ELECTRODE DEPTH GAUGE
- HIRES ULTRA BTE TEMPLATE
- HIRES ULTRA CI HIFOCUS MS ELECTRODE
- HIRES ULTRA CI HIFOCUS SLIMJ ELECTRODE
- HIRES ULTRA COIL GAUGE
- HIRES ULTRA MAGNET INSERTION TOOL
- HIRES ULTRA MAGNET PUSHER TOOL
- HIRES ULTRA MAGNET TOOL KIT
- HIRES ULTRA MOCK UP
- HIRES ULTRA RECESS GAUGE
- HIRES ULTRA REPLACEMENT MAGNET
- HIRES ULTRA REUSABLE SURGICAL TOOL KIT
- HIRES ULTRA TEMPORARY NON MAGNETIC PLUG
- MRI ANTENNA COIL COVER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.