Medical device licence · 103509 · Class 3
HARMONY PRENATAL TEST
Yes: licensed in Canada
Licence status Issued (active); first licensed September 4, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103509
- Licence holder
- Roche Molecular Systems, IncBranchburg, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 4, 2019
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARIOSA CELL-FREE DNA SYSTEM (ACFS) SOFTWARE
- CONCERTO IMAGER IVD
- HARMONY PRENATAL TEST
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.