Medical device licence · 84989 · Class 2
XLR8 FOAM KIT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 84989
- Licence holder
- Genadyne Biotechnologies, Inc.Hicksville, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 27, 2011
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYBRID DRESSING
- SPIRO FOAM DRESSING KIT
- XLR8 DUO INSTILL FOAM DRESSING KIT
- XLR8 FOAM KIT
- XLR8 FOAM KIT THIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.