Medical device licence · 105894 · Class 2
ITERO ELEMENT 5D PLUS MOBILE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105894
- Licence holder
- Align Technology, Ltd.San Jose, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 26, 2021
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ITERO ELEMENT 5D PLUS MOBILE DENTAL IMAGING SYSTEM
- ITERO ELEMENT 5D PLUS, SCANNING UNIT
- ITERO ELEMENT 5D PLUS, SCANNING UNIT
- ITERO ELEMENT 5D SCANNER SLEEVES
- ITERO PLUS MOBILE COMPUTING UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.