Medical device licence · 113086 · Class 3
HELIX
Yes: licensed in Canada
Licence status Issued (active); first licensed April 10, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113086
- Licence holder
- Deka M.E.L.A. S.R.L.Calenzano, FI, Italy
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 10, 2025
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1.5" HANDPIECE
- 2" HANDPIECE
- 4" HANDPIECE
- 7" HANDPIECE
- COLLIMATED HANDPIECE
- HELIX
- SCANNER OPEN DISTAL END
- SCANNER UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.