Medical device licence · 107046 · Class 2
FOB GOLD
Yes: licensed in Canada
Licence status Issued (active); first licensed November 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107046
- Licence holder
- Sentinel Ch. SpaMilan, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 26, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOB GOLD CALIBRATOR WIDE
- FOB GOLD CONTROL SET WIDE
- FOB GOLD NG WIDE
- FOB GOLD SCREEN DILUENT
- FOB GOLD TUBE SCREEN
- SENTIFIT FOB GOLD LATEX WIDE
- SENTIFIT PIERCETUBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.