Medical device licence · 82749 · Class 2
NOVOPEN ECHO (INSULIN DELIVERY DEVICE)
Yes: licensed in Canada
Licence status Issued (active); first licensed May 4, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82749
- Licence holder
- Novo Nordisk ABagsvaerd, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- May 4, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NOVOPEN ECHO
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.