Medical device licence · 106142 · Class 2
SURESMILE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 14, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106142
- Licence holder
- OrametrixBerlin, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 14, 2021
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SURESMILE ALIGNER
- SURESMILE RETAINER
- SURESMILE TEMPLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.