Medical device licence · 94549 · Class 2
IMAGE FILING SOFTWARE NAVIS-EX
Yes: licensed in Canada
Licence status Issued (active); first licensed January 16, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94549
- Licence holder
- Nidek Co., Ltd.Gamagori, 23, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 16, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AL-SCAN VIEWER FOR NAVIS-EX
- CEM VIEWER FOR NAVIS-EX
- GS VIEWER FOR NAVIS-EX
- MP VIEWER FOR NAVIS-EX
- NAVIS-EX
- OCT VIEWER FOR NAVIS-EX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.