Medical device licence · 112078 · Class 2
SKY PRO GUIDE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112078
- Licence holder
- Bredent Medical Gmbh & Co. KgSenden, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 25, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SKY GUIDED DRILL SLEEVE
- SKY GUIDED FIXATION PIN SLEEVE
- SKY PRO GUIDE SURGICAL TRAY 1
- SKY TISSUE PUNCH GUIDED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.