Medical device licence · 91691 · Class 2
G-EYE SYSTEM (PENTAX)
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed July 17, 2013; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 91691
- Licence holder
- Smart Medical Systems LtdRa'Anana, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 17, 2013
- Ended
- July 29, 2019
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- G-EYE ENDOSCOPE
- G-EYE LEAK TESTER
- NAVIAID AB-F DISPOSABLE
- NAVIAID AB-R DISPOSABLE
- NAVIAID ABC DISPOSABLE
- NAVIAID G-EYE ENDOSCOPE
- NAVIAID SPARK2C
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.