Medical device licence · 110466 · Class 2
BME DRILL KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 27, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110466
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- November 27, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BME ELITE IMPLANT DRILL GUIDE KIT
- BME ELITE IMPLANT DRILL KIT
- BME ELITE Y IMPLANT DRILL GUIDE KIT
- DRILL KIT FOR BME SPEED
- DRILL KIT WITH DRILL BIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.