Medical device licence · 106389 · Class 3
DARWIN
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106389
- Licence holder
- Luvo Medical Technologies, Inc.Cambridge, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 14, 2021
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DARWIN
- DARWIN DIODE LASER HANDPIECE
- DARWIN FACE THERMAL RF HANDPIECE
- DARWIN FACE THERMAL RF TIPS
- DARWIN HIFU CARTRIDGES
- DARWIN HIFU HANDPIECE
- DARWIN IPL HANDPIECE
- DARWIN IPL HANDPIECE FILTER
- DARWIN NEEDLE RF
- DARWIN NEEDLE RF HANDPIECE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.