Medical device licence · 92475 · Class 2
XLR8 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 12, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92475
- Licence holder
- Genadyne Biotechnologies, Inc.Hicksville, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 12, 2013
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABDOMINAL DRESSING
- ABDOMINAL DRESSING KIT
- BRIDGE DRESSING
- PVA FOAM
- PVA FOAM KIT
- XLR8 BRIDGE FOAM KIT
- XLR8 DUO ABDOMINAL DRESSING KIT
- XLR8 DUO BRIDGE FOAM DRESSING KIT
- XLR8 DUO PVA FOAM DRESSING KIT
- XLR8 FILM
- XLR8 NPWT SYSTEM
- XLR8 PVA FOAM KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.