Medical device licence · 100164 · Class 2
COBAS M511 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100164
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 8, 2017
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS M 511 INTEGRATED HEMATOLOGY ANALYZER
- DIGIMAC3 CALIBRATOR
- DIGIMAC3 CLEAN
- DIGIMAC3 CONTROL
- DIGIMAC3 RETICULOCYTES
- DIGIMAC3 SLIDES
- DIGIMAC3 STAIN PACK
- DIGIMAC3 WASH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.