Medical device licence · 100846 · Class 2
0072/ OMNERA 400A
Yes: licensed in Canada
Licence status Issued (active); first licensed April 12, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100846
- Licence holder
- Arcoma AbVaxjo, Sweden
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 12, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 0072/ OMNERA 400A
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 “omnera”. A notice may cover another product or only some lots: read it to see what it covers.
- 0180/OMNERA 400T (2021-05-17)June 17, 2021 · 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.