Medical device licence · 103434 · Class 2
SET IOPTIMA INT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 12, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103434
- Licence holder
- Bien-Air Dental SaBienne, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 12, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SET IOPTIMA INT-1XMX2-FULL
- SET IOPTIMA INT-1XMX2-LIGHT
- SET IOPTIMA INT-2XMX2-FULL
- SET IOPTIMA INT-2XMX2-LIGHT
- SET IOPTIMA INT-MX2+MXI-FULL
- SET IOPTIMA INT-MX2+MXI-LIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.