Medical device licence · 97638 · Class 2
THUNDERBOLT EIA
Yes: licensed in Canada
Licence status Issued (active); first licensed August 31, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97638
- Licence holder
- Gold Standard Diagnostics, LlcDavis, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- August 31, 2016
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- THUNDERBOLT EIA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.