ApprovalTrail

Medical device licence · 1977 · Class 3

EXACTECH BLOOD GLUCOSE TESTING SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed April 1, 1999; ended October 31, 2005. It is in Health Canada’s archive of licences no longer in force.
Licence number
1977
Licence holder
Abbott Laboratories Medisense ProdBedford, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 1, 1999
Ended
October 31, 2005
Devices covered
7

Devices on this licence

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

  • EXACTECH BLOOD GLUCOSE TEST STRIPS (ELECTRODES)
  • EXACTECH CHECK STRIP
  • EXACTECH ELECTRODES
  • EXACTECH GLUCOSE CONTROL SOLUTIONS
  • EXACTECH SENSOR KIT - CARD MODEL
  • EXACTECH SENSOR KIT - PEN MODEL
  • PECISION GLUCOSE CONTROL SOLUTIONS

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