Medical device licence · 101138 · Class 2
AQUILEX FLUID CONTROL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 30, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101138
- Licence holder
- Novanta Medical GmbhBerlin, 11, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 30, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AQUILEX FLUID CONTROL SYSTEM
- TUBE SET FOR IRRIGATION, SINGLE-USE
- TUBE SET FOR SUCTION, SINGLE-USE
- TUBE SET FOR VACUUM, REUSABLE
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 “aquilex”. A notice may cover another product or only some lots: read it to see what it covers.
- Aquilex Fluid Control System and Aquilex Fluid Control System Pump AssemblySeptember 3, 2024 · General hospital and personal use · Performance · Type II
- Aquilex Fluid Control SystemAugust 15, 2023 · General hospital and personal use · Performance · Type II
- Aquilex Fluid Control SystemOctober 14, 2022 · General hospital and personal use · Performance · Type II
- Aquilex Fluid Control System (2019-08-14)August 30, 2019 · 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.