Medical device licence · 107910 · Class 2
BIOFEEDBACK AND STIMULATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107910
- Licence holder
- Edan Instruments, Inc.Shenzhen, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 29, 2022
- Devices covered
- 8
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 ADHESIVE SENSOR, APPLIED TO RECTUM, DISPOSABLE
- EMG/STIMULATION SENSOR ADHESIVE SENSOR, APPLIED TO SKIN SURFACE, DISPOSABLE
- EMG/STIMULATION SENSOR INTRACAVITY SENSOR, APPLIED TO RECTUM, REUSABLE
- EMG/STIMULATION SENSOR INTRACAVITY SENSOR, APPLIED TO VAGINA, DISPOSABLE
- EMG/STIMULATION SENSOR INTRACAVITY SENSOR, APPLIED TO VAGINA, REUSABLE
- STRESS PROBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.