Medical device licence · 34414 · Class 4
SOFTWARE FOR MODULAR ANALYTICS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 29, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 34414
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- November 29, 2001
- Devices covered
- 30
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 6000 ANALYZER SERIES SYSTEM SOFTWARE INSTALLATION VERSION 06-02
- COBAS 6000 ANALYZER SERIES SYSTEM SOFTWARE INSTALLATION VERSION 06-03
- COBAS 6000 SOFTWARE VERSION 06-01
- COBAS 8000 MODULAR ANALYZER SERIES -SOFTWARE VERSION 06-07
- COBAS 8000 MODULAR ANALYZER SERIES SOFTWARE VERSION 06-04
- COBAS 8000 MODULAR ANALYZER SERIES SOFTWARE VERSION 06-05
- COBAS 8000 MODULAR ANALYZER SERIES SOFTWARE VERSION 06-06
- COBAS 8000 MODULAR ANALYZER SERIES SYSTEM SOFTWARE VERSION 06-08
- COBAS 8000 MODULAR ANALYZER SERIES SYSTEM SOFTWARE VERSION 06-09
- COBAS 8000 MODULAR ANALYZER SERIES SYSTEM SOFTWARE VERSION 06-10
- COBAS 8000 MODULAR ANALYZER SERIES SYSTEM SOFTWARE VERSION 06-11
- COBAS 8000 SOFTWARE VERSION 05-02
- COBAS 8000 SOFTWARE VERSION 06-02
- COBAS 8000 SOFTWARE VERSION 06-03
- COBAS E411 ANALYZER INSTRUMENT SOFTWARE VERSION 03-02
- COBAS E411 SOFTWARE VERSION 02-04
- COBAS E411 SOFTWARE VERSION 02-06
- COBAS E411 SOFTWARE VERSION 02-07
- COBAS E411 SOFTWARE VERSION 02-08
- COBAS E411 SOFTWARE VERSION 03-01
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 02-02
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 02-03
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 03-01
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 03-02
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 03-03
- COBAS PRO INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 03-04
- COBAS PURE INTEGRATED SOLUTIONS INSTRUMENT SOFTWARE VERSION 01-02
- COBAS PURE INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 01-03
- COBAS PURE INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 01-04
- COBAS PURE INTEGRATED SOLUTIONS SYSTEM SOFTWARE VERSION 01-05
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.