Medical device licence · 80556 · Class 2
NOVOPEN 4
Yes: licensed in Canada
Licence status Issued (active); first licensed August 27, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80556
- Licence holder
- Novo Nordisk ABagsvaerd, --, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 27, 2009
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NOVOPEN 4
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 “novopen”. A notice may cover another product or only some lots: read it to see what it covers.
- Novopen 5 and Novopen Echo (2017-07-05)July 18, 2017 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.