Medical device licence · 97401 · Class 2
ENDOSCOPE EN-580T
Yes: licensed in Canada
Licence status Issued (active); first licensed July 28, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97401
- Licence holder
- Fujifilm CorporationMinato-Ku, 13, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 28, 2016
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BALLOON
- BALLOON CONTROLLER
- CLEANING ADAPTER
- ENDOSCOPE
- HOOD
- OPTILITE HEVYLITE IGG KAPPA KIT
- OVER-TUBE
- SCA MOTILITY AND CONCENTRATION (LITE EDITION)
- TUBE KIT
- VIDEO ENDOSCOPE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.