Medical device licence · 108646 · Class 3
NORDLYS MINI
Yes: licensed in Canada
Licence status Issued (active); first licensed December 14, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108646
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 14, 2022
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1550 APPLICATOR
- 1940 APPLICATOR
- FRAX 1550 APPLICATOR
- FRAX 1940 APPLICATOR
- FRAX ARM KIT FOR YDUN
- FRAX PRO LASER SYSTEM
- NORDLYS MINI
- NORDLYS MINI ARM KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.