Medical device licence · 107355 · Class 2
LEONE EXTRAORAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 1, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107355
- Licence holder
- Leone S.P.A.Sesto Fiorentino, FI, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 1, 2022
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHIN REPLACEMENT M0790-00
- ELASTICS REPLACEMENT M0790-00
- EXORAL FACEBOW 045
- EXORAL FACEBOW 051
- FACEBOW STOP SCREW KIT
- FACEBOW STOP SCREWS
- HEAD CAP FOR SAFETY MODULE
- HEADGEAR W/CHIN CAP
- NECK PAD FOR SAFETY MODULE
- SAFETY MODULE HEAVY
- SAFETY MODULE LIGHT
- SAFETY MODULE MEDIUM
- WELDABLE STOP SCREWS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.