Medical device licence · 106446 · Class 3
ARCHITECT I SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 22, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106446
- Licence holder
- Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 22, 2021
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT "I" SYSTEM - "I" 1000SR PROCESSING MODULE
- ARCHITECT "I" SYSTEM - "I" 2000SR
- ARCHITECT "I" SYSTEM - COMPUTER MEMORY UPGRADE
- ARCHITECT "I" SYSTEM - SCC CPU SIZE CODE CHANGE
- ARCHITECT SYSTEM - SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.