Medical device licence · 77445 · Class 2
GENADYNE NPWT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 23, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 77445
- Licence holder
- Genadyne Biotechnologies, Inc.Hicksville, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 23, 2008
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASTRA
- ASTRA NPWT PUMP
- GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- GENADYNE A4-XLR8 NPWT
- GENADYNE DUO NPWT SYSTEM
- GENADYNE UNO PLUS CANISTER
- GENADYNE UNO PLUS NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- GENADYNE UNO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- UNO WOUND THERAPY KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.