Medical device licence · 104247 · Class 3
BIOFLEX MULTIPORT SYSTEM (MCU IV)
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104247
- Licence holder
- Meditech International Inc.Toronto, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 6, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOFLEX DUO+ 180 TREATMENT HEAD
- BIOFLEX DUO+ 240 TREATMENT HEAD
- BIOFLEX DUOFLEX+ 120 TREATMENT HEAD
- BIOFLEX DUOFLEX+ 180 TREATMENT HEAD
- BIOFLEX LASER THERAPY SYSTEM SOFTWARE
- BIOFLEX LD-I 200 TREATMENT HEAD
- BIOFLEX LD-R 100 TREATMENT HEAD
- BIOFLEX MULTIPORT SYSTEM MAIN CONTROLLER UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.