Medical device licence · 82560 · Class 4
COBAS 4800 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 14, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82560
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- April 14, 2010
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 4800 - COBAS X480 MODULE
- COBAS 4800 - COBAS Z480 MODULE
- COBAS 4800 SYSTEM COBAS HCV ANALYSIS PACKAGE (AP)
- COBAS 4800 SYSTEM SOFTWARE VERSION 2.2
- COBAS 4800 SYSTEM SOFTWARE VERSION 2.3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.