Medical device licence · 107108 · Class 2
N1
Yes: licensed in Canada
Licence status Issued (active); first licensed December 3, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107108
- Licence holder
- Nobel Biocare AbGoteborg, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 3, 2021
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BONE MILL NOBEL BIOCARE N1 TCC
- GUIDED PILOT DRILL NOBEL BIOCARE N1
- IMPLANT DRIVER NOBEL BIOCARE N1 TCC
- OSSEODIRECTOR NOBEL BIOCARE N1
- OSSEOSHAPER 1 NOBEL BIOCARE N1
- OSSEOSHAPER 2 NOBEL BIOCARE N1
- OSSEOSHAPER EXTENSION NOBEL BIOCARE N1
- SCREW TAP REPAIR TOOL NOBEL BIOCARE N1
- SCREWDRIVER MACHINE NOBEL BIOCARE N1 BASE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.