Medical device licence · 63215 · Class 4
ARCHITECT "I" SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 14, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 63215
- Licence holder
- Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 14, 2003
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCHITECT "I" SYSTEM - I1000SR PROCESSING MODULE - CLASS 2
- ARCHITECT "I" SYSTEM - I2000SR PROCESSING MODULE - CLASS 4
- ARCHITECT SYSTEM - SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.