Medical device licence · 76864 · Class 2
THEOPHYLLINE
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76864
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- April 18, 2008
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS INTEGRA THEOPHYLLINE (THEO)
- COBAS INTEGRA THEOPHYLLINE FOR COBAS C SYSTEMS
- THEO2 (ONLINE TDM THEOPHYLINE) FOR COBAS C SYSTEMS
- THEOPHYLLINE GEN.2 THE-2 FOR COBAS C ANALYZERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.