Medical device licence · 90317 · Class 3
REVACLEAR
Yes: licensed in Canada
Licence status Issued (active); first licensed December 12, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90317
- Licence holder
- Vantive Health GmbhGlattpark (Opfikon), Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- December 12, 2012
- 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
- POLYFLUX REVACLEAROctober 6, 2016 · Medical devices · Type I
- Polyflux Revaclear Dialyzers (2014-11-12)November 21, 2014 · 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.