Medical device licence · 67739 · Class 3
ENGSTROM CARESTATION
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67739
- Licence holder
- Datex-Ohmeda, Inc.Madison, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 14, 2005
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENGSTROM CARESTATION - CANADIAN SOFTWARE
- ENGSTROM CARESTATION - DISS FEMALE SEQUENTIAL PROBE HOSE ASSEMBLIES
- ENGSTROM CARESTATION - DISS FEMALE/NEMA - PNEUMATIC/ELECTRIC CONFIGURATION
- ENGSTROM CARESTATION - EVIEW ASSEMBLY
- ENGSTROM CARESTATION - EXHALATION VALVE HEATER OPTION
- ENGSTROM CARESTATION - EXHALATION VALVE HEATER OPTION CABLE
- ENGSTROM CARESTATION - EXHALATION VALVE KITS
- ENGSTROM CARESTATION - EXPIRATORY FLOW SENSOR
- ENGSTROM CARESTATION - MAIN UNIT
- ENGSTROM CARESTATION - NEONATAL FLOW SENSOR
- ENGSTROM CARESTATION - NEONATAL FLOW SENSOR CABLE
- ENGSTROM CARESTATION - NEONATAL SOFTWARE OPTION
- ENGSTROM CARESTATION - SOFTWARE FIELD UPGRADE
- ENGSTROM CARESTATION - SOFTWARE NIVO OPTION
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 “engstrom”. A notice may cover another product or only some lots: read it to see what it covers.
- Engstrom Pro, Carescape, Engstrom CarestationMay 9, 2022 · Anaesthesiology · Electrical defect · Type II
- Engstrom Carestation (2015-01-29)February 6, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.