Medical device licence · 95462 · Class 2
OPTIMA MCX
Yes: licensed in Canada
Licence status Issued (active); first licensed July 17, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95462
- Licence holder
- Bien-Air Dental SaBienne, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 17, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3P CABLE SYSTEM
- KIT AP OPTIMA MCX + SUPPORT
- MCX MICROMOTOR LED
- OPTIMA MCX
- OPTIMA MCX SET
- POWER SUPPLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.