Medical device licence · 115008 · Class 2
BIOFLEX SHOCKWAVE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 3, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115008
- Licence holder
- Meditech International Inc.Toronto, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 3, 2026
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOFLEX SHOCKWAVE ACUPUNCTURE TRANSMITTER
- BIOFLEX SHOCKWAVE DEEP TITANIUM TRANSMITTER
- BIOFLEX SHOCKWAVE DEEP TRANSMITTER
- BIOFLEX SHOCKWAVE FOCUS TRANSMITTER
- BIOFLEX SHOCKWAVE HANDPIECE KIT
- BIOFLEX SHOCKWAVE RADIAL TRANSMITTER
- BIOFLEX SHOCKWAVE REVISION KIT
- BIOFLEX SHOCKWAVE SYSTEM
- BIOFLEX SHOCKWAVE VIBRATION HANDPIECE KIT
- BIOFLEX SHOCKWAVE VIBRATION TRANSMITTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.