Medical device licence · 102638 · Class 2
PREPSTART H2O SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 27, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102638
- Licence holder
- Danville MaterialsCarlsbad, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 27, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASSY, NOZ PS H2O
- H2O HANDPIECE ASSEMBLY
- PREPSTART H2O
- PREPSTART H2O RETROFIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.