Medical device licence · 77804 · Class 3
HYPERFIL-DC
Yes: licensed in Canada
Licence status Issued (active); first licensed August 20, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77804
- Licence holder
- Parkell, Inc.Edgewood, NY, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 20, 2008
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYPERFIL DC, ENAMEL SHADE
- HYPERFIL DC, UNIVERSAL SHADE
- HYPERFIL-DC INTRO KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.