Medical device licence · 103378 · Class 3
PRISMAX
Yes: licensed in Canada
Licence status Issued (active); first licensed August 1, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103378
- Licence holder
- Vantive Health GmbhGlattpark (Opfikon), Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- August 1, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRISMAX
- PRISMAX DIGITAL COMMUNICATION MODULE
- PRISMAX UPGRADE KIT
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 “prismax”. A notice may cover another product or only some lots: read it to see what it covers.
- Prismax and Thermax SystemsAugust 6, 2025 · Gastroenterology and urology - Haematology · Performance · Type II
- Prismax Control UnitMarch 29, 2022 · Gastroenterology and urology · Inaccurate test or measurement results · Type II
- PRISMAX CONTROL UNIT (2021-10-05)October 21, 2021 · Medical devices · Medical devices · Type II
- PrisMax Control Unit (2021-01-13)January 29, 2021 · Medical devices · Medical devices · Type II
- PrisMax Control Unit (2021-01-13)January 22, 2021 · Medical devices · Medical devices · Type II
- PrisMax Control Unit (2020-03-30)April 8, 2020 · Medical devices · COVID - Medical devices · Type I
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.