Medical device licence · 64184 · Class 2
CRITICOOL
Yes: licensed in Canada
Licence status Issued (active); first licensed April 19, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64184
- Licence holder
- Belmont Medical TechnologiesBillerica, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 19, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONNECTING TUBE
- CORE ADAPTOR
- CORE SENSOR
- CRITICOOL CONTROL UNIT
- FILTER
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.