Medical device licence · 8588 · Class 3
CARDIAC SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed July 29, 1999; ended August 9, 2007. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 8588
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 29, 1999
- Ended
- August 9, 2007
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIAC SYSTEM - CARDIAC MARKER M (MYOGLOBIN)
- CARDIAC SYSTEM - CARDIAC MARKER READER
- CARDIAC SYSTEM - CARDIAC MARKER T (TROPONIN T)
- CARDIAC SYSTEM - D-DIMER
- CARDIAC SYSTEM - PRO BNP TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.