Medical device licence · 26686 · Class 3
CARDIOLAB SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 15, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 26686
- Licence holder
- Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 15, 2001
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIOLAB ALTIX
- CARDIOLAB ALTIX AI.I
- CARDIOLAB SYSTEM - 3RD PARTY INTERFACE
- CARDIOLAB SYSTEM - ACQUISITION UPGRADE CLABIIPLUS AMPLIFIER
- CARDIOLAB SYSTEM - AMPLIFIER
- CARDIOLAB SYSTEM - CABLE STIM INPT CLABII+
- CARDIOLAB SYSTEM - CLAB II PLUS - ACQUISITION MODULE
- CARDIOLAB SYSTEM - CLIENT SOFTWARE AND HARDWARE
- CARDIOLAB SYSTEM - INTEGRATED ELECTRONICS BOX
- CARDIOLAB SYSTEM - MAIN UNIT
- CARDIOLAB SYSTEM - SIMULATOR
- CARDIOLAB SYSTEM - SOFTWARE OPTIONS
- CARDIOLAB SYSTEM - SYSTEM UPGRADES
- MLCL CLIENT SOFTWARE
- MLCL CLIENT SOFTWARE ALTIX AI.I
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 “cardiolab”. A notice may cover another product or only some lots: read it to see what it covers.
- CardioLab System - Amplifier (2018-09-17)May 8, 2020 · Medical devices · Medical devices · Type II
- ComboLab System - Main Unit, CardioLab System - Main Unit, Mac-Lab System - Main Unit, and Mac-Lab Systems - Integrated Electronics Box (2018-06-14)July 27, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.