ApprovalTrail

Medical device licence · 80403 · Class 2

ARCHITECT C4000 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed August 6, 2009. It is in Health Canada’s list of active licences.
Licence number
80403
Licence holder
Abbott Laboratories Co.Saint-Laurent, Quebec, Canada
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 6, 2009
Devices covered
4

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ARCHITECT C4000 SYSTEM - ARTICULATING ARM
  • ARCHITECT C4000 SYSTEM - INTEGRATED PROCESSING MODULE
  • ARCHITECT C4000 SYSTEM - INTEGRATED RSH KIT
  • ARCHITECT C4000 SYSTEM - PROCESSING MODULE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.