Medical device licence · 94375 · Class 2
MRXPERION MR INJECTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 19, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94375
- 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
- December 19, 2014
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 250CM SINGLE PATIENT DISPOSABLE
- ISI2 MODULE
- MEDRAD MRXPERION 250CM SINGLE PATIENT DISPOSABLE
- MEDRAD MRXPERION MULTI-PATIENT KIT
- MRXPERION MR INJECTION SYSTEM
- MRXPERION MR INJECTION SYSTEM SYRINGE KIT
- MULTI-PATIENT CLAMP
- MULTI-PATIENT KIT
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 “mrxperion”. A notice may cover another product or only some lots: read it to see what it covers.
- MRXPERION MR INJECTION SYSTEM (2016-06-06)June 30, 2016 · Medical devices · Medical devices · Type II
- MRXPERION MR INJECTION SYSTEM (2016-06-24)June 24, 2016 · Medical devices · Medical devices · Type II
- MRXPERION MR INJECTION SYSTEM(2015-08-19)October 8, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.