Medical device licence · 102634 · Class 2
DIRECT LDL
Yes: licensed in Canada
Licence status Issued (active); first licensed March 26, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102634
- Licence holder
- Sekisui Diagnostics P.E.I. Inc.Charlottetown, PE, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- March 26, 2019
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECT LDL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.