Medical device licence · 98046 · Class 2
FLEX ROBOTIC SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed November 17, 2016; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 98046
- Licence holder
- Medrobotics CorporationRaynham, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 17, 2016
- Ended
- July 29, 2019
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEX ADAPTER
- FLEX BASE
- FLEX CAMERA
- FLEX CONSOLE
- FLEX DRIVE
- FLEX FENESTRATED GRASPER
- FLEX LASER HOLDER
- FLEX MONOPOLAR (MARYLAND) DISSECTOR
- FLEX MONOPOLAR NEEDLE KNIFE
- FLEX MONOPOLAR SCISSOR
- FLEX MONOPOLAR SPATULA
- FLEX NEEDLE DRIVER
- FLEX RETRACTOR SYSTEM
- FLEX SCOPE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.