Medical device licence · 85575 · Class 2
INNOVANCE PFA-200
Yes: licensed in Canada
Licence status Issued (active); first licensed March 22, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85575
- Licence holder
- Siemens Healthcare Diagnostics Products GmbhMarburg, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group
- First licensed
- March 22, 2011
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INNOVANCE PFA-200 SYSTEM
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
- Innovance D-DimerFebruary 9, 2017 · Medical devices · Medical devices · Type II
- INNOVANCE PFA P2Y (2015-12-30)January 22, 2016 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.