Medical device licence · 108907 · Class 3
ATELLICA DCA TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 20, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 108907
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 20, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACR ATELLICA DCA ANALYZER REAGENT KIT
- ATELLICA DCA MODULE
- ATELLICA POC SOLUTION DISPLAY
- HBA1C CONTROLS ATELLICA DCA ANALYZER CONTROLS KIT
- HBA1C DX ATELLICA DCA ANALYZER REAGENT KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.