Medical device licence · 110960 · Class 2
BOLT
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110960
- Licence holder
- Gold Standard Diagnostics, LlcDavis, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 19, 2024
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BOLT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.