Medical device licence · 94115 · Class 3
SENSIS VIBE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 21, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94115
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 21, 2014
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEMOMED POD
- NURSE WORKSTATION
- POST-PROCESSING WORKSTATION
- SENSIS SERVER
- SENSIS SYSTEM SOFTWARE
- SENSIS VIBE
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 “sensis”. A notice may cover another product or only some lots: read it to see what it covers.
- Sensis VibeDecember 2, 2022 · Radiology · Device compatibility - Performance · Type II
- Sensis VibeJanuary 31, 2022 · Radiology · Performance · Type II
- Sensis (2020-07-24)August 28, 2020 · Medical devices · Medical devices · Type II
- Sensis (2019-05-29)June 14, 2019 · Medical devices · Medical devices · Type III
- Axiom Sensis Hemodynamic Application (2017-04-17)June 5, 2017 · Medical devices · Medical devices · Type II
- Axiom Sensis System Electrophysiology and Hemodynamic Application (2017-04-17)May 16, 2017 · Medical devices · Medical devices · Type II
- SensisMay 16, 2017 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.