Medical device licence · 754 · Class 4
IMMUNOASSAY ANALYZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 18, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 754
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- January 18, 1999
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COBAS 6000 - E601
- COBAS 8000 E602 IMMUNOASSAY ANALYZER
- COBAS E 411 IMMUNOASSAY ANALYZER
- MODULAR ANALYTICS E COMBINATIONS ANALYZER (E170)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.