Medical device licence · 106933 · Class 2
INNOVANCE ANTI-XA
Yes: licensed in Canada
Licence status Issued (active); first licensed November 4, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106933
- Licence holder
- Siemens Healthcare Diagnostics Products GmbhMarburg, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- November 4, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INNOVANCE ANTI-XA
- INNOVANCE APIXABAN CONTROLS
- INNOVANCE APIXABAN STANDARDS
- INNOVANCE EDOXABAN CONTROLS
- INNOVANCE EDOXABAN STANDARDS
- INNOVANCE RIVAROXABAN CONTROLS
- INNOVANCE RIVAROXABAN STANDARDS
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 “innovance”. A notice may cover another product or only some lots: read it to see what it covers.
- INNOVANCE® VWF Ac assayJuly 4, 2025 · Haematology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.