Medical device licence · 21029 · Class 3
RAPIDPOINT COAGULATION SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 1, 2000; ended October 1, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 21029
- Licence holder
- Bayer Healthcare Llc Subsidiary Of Bayer CorporationMishawaka, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 1, 2000
- Ended
- October 1, 2004
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAPIDPOINT COAGULATION SYSTEM - INSTRUMENT
- RAPIDPOINT COAGULATION SYSTEM - LOW RANGE HEPARIN MANAGEMENT TEST (LHMT)
- RAPIDPOINT SYSTEM - ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)
- RAPIDPOINT SYSTEM - HEPARIN MANAGEMENT PANEL LEVEL 1 AND 2
- RAPIDPOINT SYSTEM - HEPARIN MONITORING TIME (HMT)
- RAPIDPOINT SYSTEM - PROTHROMBIN (PT)
- RAPIDPOINT SYSTEM - PT-NC (PROTHROMBIN ON NON CITRATED WHOLE BLOOD)
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 “rapidpoint”. A notice may cover another product or only some lots: read it to see what it covers.
- RAPIDPoint® 500 Blood Gas SystemsMarch 17, 2026 · Chemistry · Performance · Type II
- Wash/Waste Cartridge For RAPIDPoint® 500 And RAPIDPoint® 500eJuly 16, 2025 · Chemistry · Performance · Type II
- RAPIDPoint® 500e Blood Gas SystemOctober 12, 2023 · Chemistry · Performance · Type II
- RAPIDPoint 500 System (2018-10-02)November 29, 2019 · Medical devices · Medical devices · Type III
- RAPIDPoint 405, 500 and RAPIDLab 1245 Blood Gas Analyzer (2018-07-24)August 17, 2018 · Medical devices · Medical devices · Type II
- Rapidpoint 405 System Measurement CartridgesSeptember 7, 2016 · Medical devices · Type III
- RAPIDPoint Blood Gas Analyzers (2016-08-12)August 26, 2016 · Medical devices · Medical devices · Type III
- RAPIDPOINT 500 CARTRIDGE LACTATE (2015-08-25)September 8, 2015 · Medical devices · Health products · Type III
- RAPIDPOINT 500 SYSTEM (2015-07-29)August 18, 2015 · Medical devices · Health products · Type III
- Rapidpoint 405, Rapidlab 1265 System Analyzers and Rapidpoint 500 System - Main Unit (2015-01-07)January 21, 2015 · Medical devices · Health products · Type III
- Rapidpoint 405 System - Analyzer (2014-09-03)September 11, 2014 · Medical devices · Medical devices · Type III
- Rapidpoint 500 system - Lactate Measurement Cartridges (2014-05-30)June 19, 2014 · Medical devices · Medical devices · Type III
- Rapidpoint and Rapidlab Systems (2013-09-24)October 31, 2013 · 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.