Medical device licence · 97725 · Class 4
PROKERA
Yes: licensed in Canada
Licence status Issued (active); first licensed September 19, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97725
- Licence holder
- Biotissue Holdings Inc. AlsoDoral, FL, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- September 19, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROKERA CLASSIC BIOLOGIC CORNEAL BANDAGE
- PROKERA PLUS BIOLOGIC CORNEAL BANDAGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.