Medical device licence · 1668 · Class 2
SPECTRIS MR INJECTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 1, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 1668
- 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
- March 1, 1999
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPECTRIS EP MR INJECTION SYSTEM
- SPECTRIS SOLARIS EP MOBILE SOLUTION - MR 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 “spectris”. A notice may cover another product or only some lots: read it to see what it covers.
- Spectris EP MR Injection SystemFebruary 28, 2017 · Medical devices · Type III
- Spectris EP MR Injection SystemFebruary 1, 2017 · 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.