Medical device licence · 105060 · Class 2
SM3 SURGERY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 25, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105060
- Licence holder
- Hiossen Inc.Fairless Hills, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 25, 2020
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AC POWER CORD
- CALIBRATION BUR
- FOOT CONTROL
- MICROMETER SL
- SM3 CONTROL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.