ApprovalTrail

Medical device licence · 116280 · Class 3

ELECTROSURGICAL UNIT

Yes: licensed in Canada

Licence status Issued (active); first licensed September 28, 2026. It is in Health Canada’s list of active licences.
Licence number
116280
Licence holder
Tentech Inc.Seoul, South Korea
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 28, 2026
Devices covered
7

Devices on this licence

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

  • 10THERMA SYSTEM
  • COUPLING FLUID
  • ELECTRODE
  • ELECTROSURGICAL UNIT
  • FOOT SWITCH
  • HANDPIECE
  • RETURN PAD

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