Medical device licence · 108981 · Class 3
ESSENZ HEART-LUNG MACHINE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 1, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 108981
- Licence holder
- Livanova Deutschland GmbhMunich, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 1, 2023
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BUBBLE SENSOR
- ESSENZ ARTERIAL CLAMP - AC ARM
- ESSENZ BUBBLE MODULE
- ESSENZ COCKPIT
- ESSENZ CONTROL UNIT
- ESSENZ CPD
- ESSENZ CPED
- ESSENZ FLOW MODULE
- ESSENZ HLM
- ESSENZ LEVEL MODULE
- ESSENZ PRESSURE MODULE
- ESSENZ RP150
- ESSENZ RP85
- ESSENZ TEMPERATURE MODULE
- ESSENZ VENOUS CLAMP
- FLOW SENSOR
- INSPIRE TEMPERATURE PROBE
- KIDS TEMPERATURE PROBE
- LEVEL CONTROL PADS
- VENOUS LINE CLAMP WITH REMOTE CONTROL
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 “essenz”. A notice may cover another product or only some lots: read it to see what it covers.
- Essenz HLMJanuary 22, 2025 · Cardiovascular · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.