Medical device licence · 90672 · Class 3
BONEBRIDGE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 13, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90672
- Licence holder
- Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 13, 2013
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BCI 602 KIT*
- BCI 602 LIFTS
- BCI 602 SIZER KIT
- BCI LIFTS
- BCI SIZER KIT
- BONEBRIDGE BCI BONE CONDUCTION IMPLANT
- REMOTE CONTROL
- SAMBA 2 BB AP UNIT
- SAMBA 2 BB POM
- SAMBA 2 BB USER KIT
- SAMBA 2 CLINICAL PACKAGES
- SAMBA 2 GO
- SAMBA 2 GO NECKLOOP
- SAMBA 2 GO SLEEVE
- SAMBA BATTERY PILL
- SAMBA BB AUDIO PROCESSOR
- SAMBA PROGRAMMING CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.