Medical device licence · 105777 · Class 2
ITERO ELEMENT 2 PLUS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105777
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 27, 2021
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ITERO ELEMENT 2 PLUS INTRA-ORAL SCANNER
- ITERO ELEMENT 2 PLUS, SCANNING UNIT
- ITERO ELEMENT SCANNER SLEEVES
- ITERO PLUS COMPUTING UNIT
- ITERO WHEEL STAND
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.