Medical device licence · 77399 · Class 2
ION SELECTIVE ELECTRODE ANALYZER MODULES
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77399
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 16, 2008
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 8000 ISE SUPPORT BOX
- COBAS ISE NEO 1800 ANALYTICAL UNIT
- COBAS ISE NEO 900 ANALYTICAL UNIT
- COBAS PRO ISE ANALYTICAL UNIT
- ISE1800 ADDITIONAL MODULE FOR COBAS 8000
- ISE900 MODULE FOR COBAS 8000
- MODULAR CORE MODULE WITH ISE600
- MODULAR EVO CORE MODULE WITH ISE600
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.