Medical device licence · 89608 · Class 2
STELLANT WITH CERTEGRA WORKSTATION
Yes: licensed in Canada
Licence status Issued (active); first licensed August 31, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89608
- Licence holder
- Bayer Medical Care Inc. Also Doing Business As Medrad, Inc.Indianola, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 31, 2012
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ISI2 MODULE
- MEDRAD STELLANT MULTI-PATIENT KIT
- MEDRAD STELLANT SINGLE PATIENT DISPOSABLE
- STELLANT WITH CERTEGRA WORKSTATION - CONTROL ROOM UNIT
- STELLANT WITH CERTEGRA WORKSTATION - DISPLAY EXTENSION CABLES
- STELLANT WITH CERTEGRA WORKSTATION - HAND SWITCH
- STELLANT WITH CERTEGRA WORKSTATION - IMAGING SYSTEM INTERFACE
- STELLANT WITH CERTEGRA WORKSTATION - INJECTOR HEAD EXTENSION CABLES
- STELLANT WITH CERTEGRA WORKSTATION - P3T ABDOMEN
- STELLANT WITH CERTEGRA WORKSTATION - P3T CARDIAC
- STELLANT WITH CERTEGRA WORKSTATION - P3T PA
- STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
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 “stellant”. A notice may cover another product or only some lots: read it to see what it covers.
- Stellant With Certegra Workstation - Stellant CtJune 5, 2017 · Medical devices · Medical devices · Type II
- STELLANT WITH CERTEGRA WORKSTATION - CONTROL ROOM UNT (2016-08-03)August 26, 2016 · Medical devices · Medical devices · Type II
- Stellant with Certegra Workstation - Stellant CT (2014-06-12)July 3, 2014 · Medical devices · Medical devices · Type II
- Medrad Stellant with Certegra Workstation(2014-05-01)May 1, 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.