Medical device licence · 93681 · Class 2
COBAS U 701 MICROSCOPY ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 5, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93681
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 5, 2014
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 6500 - COBAS U CUVETTE
- COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
- COBAS 6500 - REFERENCE CUVETTE COBAS U701
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.