Medical device licence · 81050 · Class 2
GENADYNE DRESSING KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 29, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81050
- Licence holder
- Genadyne Biotechnologies, Inc.Hicksville, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 29, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENADYNE A4 (W/O ANTIMICROBIAL GAUZE) FLAT DRAIN
- GENADYNE A4 WOUND SEALING KITS WITH CHANNEL DRAIN
- GENADYNE A4 WOUND SEALING KITS WITH FLAT DRAIN
- GENADYNE A4 WOUND SEALING KITS WITH ROUND DRAIN
- GENADYNE XLR8 (W/O NPWT TUBING & ANTIMICROBIAL GAUZE) FLAT DRAIN
- GENADYNE XLR8 WOUND SEALING KITS (W/O NPWT TUBING) CHANNEL DRAIN
- GENADYNE XLR8 WOUND SEALING KITS (W/O NPWT TUBING) FLAT DRAIN
- GENADYNE XLR8 WOUND SEALING KITS (W/O NPWT TUBING) ROUND DRAIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.