Medical device licence · 101318 · Class 3
REVACLEAR
No longer licensed: cancelled
Licence status Cancelled; first licensed June 29, 2018; ended February 21, 2025. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101318
- Licence holder
- Gambro Renal Products Inc.Opelika, AL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 29, 2018
- Ended
- February 21, 2025
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REVACLEAR CAPILLARY DIALYZER
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 “revaclear”. A notice may cover another product or only some lots: read it to see what it covers.
- Revaclear 400 Dialyzer; Revaclear 300 DialyzerDecember 2, 2022 · Anaesthesiology · Performance · Type II
- REVACLEAR Dialyzer (2019-05-29)June 21, 2019 · Medical devices · Medical devices · Type II
- Polyflux Revaclear Max Dialyzer (2017-12-15)September 7, 2018 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.