Medical device licence · 100647 · Class 2
HDL-CHOLESTEROL GEN.4
Yes: licensed in Canada
Licence status Issued (active); first licensed February 23, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100647
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 23, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HDLC4 (HDL-CHOLESTEROL GEN.4)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.