Medical device licence · 76942 · Class 4
ORTHO SUMMIT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 25, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76942
- Licence holder
- Ortho-Clinical Diagnostics, Inc.Athens, OH, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- April 25, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORTHO SUMMIT SYSTEM - ASSAY SOFTWARE WORKSTATION
- ORTHO SUMMIT SYSTEM - PROCESSOR
- ORTHO SUMMIT SYSTEM - PROCESSOR WORKSTATION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.