ApprovalTrail

Medical device licence · 112142 · Class 3

BODYTOM 64

Yes: licensed in Canada

Licence status Issued (active); first licensed November 6, 2024. It is in Health Canada’s list of active licences.
Licence number
112142
Licence holder
Samsung Hme America, Inc.Danvers, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 6, 2024
Devices covered
2

Devices on this licence

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

  • BODYTOM 64
  • WORKSTATION CART

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