ApprovalTrail

Medical device licence · 115785 · Class 3

SMARTREGEN

Yes: licensed in Canada

Licence status Issued (active); first licensed July 14, 2026. It is in Health Canada’s list of active licences.
Licence number
115785
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
July 14, 2026
Devices covered
4

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BIOSTIMUL HANDPIECE
  • DENTAL HANDPIECE
  • DENTAL HANDPIECE TIP
  • SMARTREGEN

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.