Medical device licence · 106394 · Class 2
ARCHITECT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106394
- Licence holder
- Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 14, 2021
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT C8000 PROCESSING MODULE
- ARCHITECT I1000SR INTEGRATED MODULE
- ARCHITECT I1000SR PROCESSING MODULE
- ARCHITECT I2000SR PROCESSING MODULE
- ARCHITECT PROCESSING MODULE
- ARCHITECT SYSTEM SOFWARE
- ICT CLEANING FLUID
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.