Medical device licence · 84483 · Class 2
SMARTSITE SYRINGE SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84483
- Licence holder
- Bd Switzerland SarlEysins, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- November 18, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SMARTSITE SYRINGE SET
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 “smartsite”. A notice may cover another product or only some lots: read it to see what it covers.
- Alaris™ Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite™ Y-site(s)May 3, 2024 · General hospital and personal use · Performance · Type II
- BD Smartsite Low Sorbing Extension SetNovember 23, 2023 · General hospital and personal use · Labelling and packaging · Type II
- Smartsite Needle-Free Vial AccessDecember 13, 2016 · Medical devices · Medical devices · Type II
- SmartSite Infusion Set model 2420-0500 (2015-11-09)January 14, 2016 · Medical devices · Health products · Type II
- SmartSite Extension Set (2015-10-20)October 20, 2015 · Medical devices · Health products · Type II
- Smartsite Needleless Connector (2014-01-22)March 18, 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.