Medical device licence · 96814 · Class 2
REGENKIT EXTRACELL
Yes: licensed in Canada
Licence status Issued (active); first licensed April 7, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96814
- Licence holder
- Regen Lab SaLe Mont-Sur-Lausanne, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 7, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REGENKIT EXTRACELL BMC
- REGENKIT EXTRACELL BMC2
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “regenkit”. A notice may cover another product or only some lots: read it to see what it covers.
- RegenKit® BCT-3December 21, 2022 · Chemistry · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.