Medical device licence · 106429 · Class 3
SIGMASTIM SIGMA
Yes: licensed in Canada
Licence status Issued (active); first licensed July 21, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106429
- Licence holder
- Sigmastim Domestic LlcTualatin, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 21, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIGMA DUAL HAND-HELD ELECTRODE ASSEMBLY
- SIGMA PATIENT STIMULUS CABLE
- SIGMA SINGLE HAND-HELD ELECTRODE ASSEMBLY
- SIGMASTIM SIGMA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.