Medical device licence · 101378 · Class 2
GUTTA-SMART
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101378
- Licence holder
- Aseptico, IncorporatedWoodinville, WA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 10, 2018
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BASE STATION
- ELECTRIC HEAT PLUGGER
- FLOW HANDPIECE
- FLOW HEATER
- GUTTA-SMART CORDLESS OBTURATION SYSTEM
- PACK HANDPIECE
- THERMAL RESPONSE TIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.