Medical device licence · 109330 · Class 3
UPATH HER2 (4B5) IMAGE ANALYSIS FOR BREAST ALGORITHM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 11, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109330
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- May 11, 2023
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UPATH HER2 (4B5) IMAGE ANALYSIS FOR BREAST ALGORITHM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.