Medical device licence · 97835 · Class 2
ELECSYS FOLATE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 13, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97835
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 13, 2016
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALSET FOLATE
- ELECSYS FOLATE III
- ELECSYS FOLATE III (FOLATE RBC APPLICATION)
- ELECSYS FOLATE III (FOLATE SERUM/PLASMA APPLICATION)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.