Medical device licence · 90411 · Class 3
UROSKOP OMNIA
Yes: licensed in Canada
Licence status Issued (active); first licensed December 28, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 90411
- Licence holder
- Siemens Healthcare GmbhErlangen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 28, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UROSKOP OMNIA
- UROSKOP OMNIA MAX
- UROSKOP OMNIA MAX - SYSTEM SOFTWARE
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 “uroskop”. A notice may cover another product or only some lots: read it to see what it covers.
- Uroskop OmniaJune 19, 2025 · Radiology · Performance · Type II
- Luminos, Uroskop and Axiom SystemsFebruary 24, 2023 · Radiology · Performance · Type II
- LUMINOS DRF MAX, UROSKOP OMNIA MAX, MULTITOM RAXApril 11, 2022 · Radiology · Software defect · Type II
- Uroskop Omnia & Uroskop Omnia Max (2020-09-11)October 2, 2020 · Medical devices · Medical devices · Type II
- YSIO Max, Luminos DRF, Uroskop Omni Max, Luminos Agile Max (2020-01-17)January 31, 2020 · Medical devices · Medical devices · Type II
- Uroskop Omnia, Uroskop Omnia Max (2019-02-07)February 22, 2019 · 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.