ApprovalTrail

Medical device licence · 114132 · Class 2

BIOGRAPH ONE

Yes: licensed in Canada

Licence status Issued (active); first licensed October 14, 2025. It is in Health Canada’s list of active licences.
Licence number
114132
Licence holder
Siemens Healthineers AgForchheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
October 14, 2025
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BIOGRAPH ONE
  • SYNGO MR

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.