Medical device licence · 109502 · Class 2
ITERO LUMINA
Yes: licensed in Canada
Licence status Issued (active); first licensed June 13, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109502
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 13, 2023
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ITERO LUMINA
- ITERO LUMINA DOA
- ITERO LUMINA INTRAORAL SCANNING UNIT
- ITERO LUMINA SCANNER SLEEVES
- ITERO LUMINA UPGRADE
- LUMINA COMPUTING UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.