Medical device licence · 115339 · Class 2
ROTARY ENGINE FILES
Yes: licensed in Canada
Licence status Issued (active); first licensed May 5, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115339
- Licence holder
- Kerr Italia S.R.L.Scafati, SA, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 5, 2026
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- K3 ROTARY FILES
- K3XF ROTARY FILES
- QUANTEC ROTARY FILES
- TF ADAPTIVE ROTARY FILES
- TF ROTARY FILES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.