Medical device licence · 62875 · Class 3
HIRES 90K
Yes: licensed in Canada
Licence status Issued (active); first licensed August 5, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62875
- Licence holder
- Advanced Bionics, LlcSylmar, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 5, 2003
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HIRES 90K - MAGNET INSERT DUMMY
- HIRES 90K - REPLACEMENT MAGNET
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 “hires”. A notice may cover another product or only some lots: read it to see what it covers.
- HiRes Ultra CI HiFocus MS & SlimJ Electrode and HiRes Ultra 3D CI with Hi Focus MS & SlimJ Electrode (2020-02-18)April 17, 2020 · Medical devices · Medical devices · Type II
- Archived – Notification to HiRes 90K Cochlear Implant Users – Advanced Bionics – For the PublicNovember 9, 2004 · Medical devices · Product safety
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.