Medical device licence · 102069 · Class 3
OMNITOM ELITE
Yes: licensed in Canada
Licence status Issued (active); first licensed November 16, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 102069
- Licence holder
- Samsung Hme America, Inc.Danvers, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 16, 2018
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMNITOM
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 “omnitom”. A notice may cover another product or only some lots: read it to see what it covers.
- OmniTomJune 14, 2023 · Radiology · Performance · Type II
- OmniTom (2020-07-16)August 14, 2020 · 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.