Medical device licence · 95402 · Class 4
OPTOMONITOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95402
- Licence holder
- Opsens, IncQuebec, QC, Canada
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 14, 2015
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPM3-DU DISPLAY UNIT
- OPM3-HU HANDLE UNIT
- OPM3-OU OPTICAL UNIT
- OPM3-OU POWER SUPPLY
- OPM3-OU-DU LAN COMMUNICATION CABLE
- OPTOMONITOR 3 CAPTURE UNIT
- OPTOMONITOR AC POWER CORD
- OPTOMONITOR DISPLAY UNIT
- OPTOMONITOR DISPLAY UNIT COMMUNICATION CABLE
- OPTOMONITOR HANDLE UNIT
- OPTOMONITOR INTERFACE CABLE
- OPTOMONITOR OPTICAL UNIT
- OPTOMONITOR POWER SUPPLY CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.