Medical device licence · 90086 · Class 3
CRITICOOL PRO SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 13, 2012; ended October 25, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 90086
- Licence holder
- Mtre Advanced Technologies Ltd.Yavne, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 13, 2012
- Ended
- October 25, 2018
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CRITICOOL PRO SYSTEM - 5 LEAD ECG KIT
- CRITICOOL PRO SYSTEM - CABLE
- CRITICOOL PRO SYSTEM - CABLE SPO2 ADAPTER CABLE
- CRITICOOL PRO SYSTEM - MAIN ASSY
- CRITICOOL PRO SYSTEM - MAIN UNIT
- CRITICOOL PRO SYSTEM - MASIMO LNCS-DC-I ADULT SENSOR
- CRITICOOL PRO SYSTEM - NIBP ACCESORY KIT
- CRITICOOL PRO SYSTEM - PACKAGING SET FOR UNIT ASSY
- CRITICOOL PRO SYSTEM - POWER CORD
- CRITICOOL PRO SYSTEM - SET BRACKETS
- CRITICOOL PRO SYSTEM - SPO2 FINGER SENSOR
- CRITICOOL PRO SYSTEM - TEMP PROBE
- CRITICOOL SYSTEM- MAIN ASSY
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 “criticool”. A notice may cover another product or only some lots: read it to see what it covers.
- Criticool Control UnitDecember 15, 2022 · Cardiovascular · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.