ApprovalTrail

Medical device licence · 109363 · Class 2

BIOFEEDBACK AND STIMULATION SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed May 19, 2023. It is in Health Canada’s list of active licences.
Licence number
109363
Licence holder
Edan Instruments, Inc.Shenzhen, 190, China
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 19, 2023
Devices covered
3

Devices on this licence

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

  • BIOFEEDBACK AND STIMULATION SYSTEM
  • CONNECTION CABLE
  • EMG/STIMULATION SENSOR

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