Medical device licence · 79071 · Class 3
CARDIOCHEK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 13, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79071
- Licence holder
- Polymer Technology Systems, Inc.Whitestown, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 13, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIOCHEK SYSTEM - ANALYZER
- CARDIOCHEK SYSTEM - PTS PANELS CHOL+HDL PANEL TEST STRIPS
- CARDIOCHEK SYSTEM - PTS PANELS CHOL+HDL+GLU TEST STRIPS
- CARDIOCHEK SYSTEM - PTS PANELS CHOLESTEROL TEST STRIPS
- CARDIOCHEK SYSTEM - PTS PANELS GLUCOSE TEST STRIPS
- CARDIOCHEK SYSTEM - PTS PANELS LIPD PANEL TEST STRIPS
- CARDIOCHEK SYSTEM - PTS PANELS TRIGLYCERIDES TEST STRIPS
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 “cardiochek”. A notice may cover another product or only some lots: read it to see what it covers.
- CardioChek System - PTS Panels CHOL+HDL+GLU test strips (2019-04-11)June 7, 2019 · Medical devices · Medical devices · Type III
- CardioChek System - PTS Panels (Cholesterol Test Strips, CHOL+HDL+GLU Test Strips) (2019-03-26)April 18, 2019 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.