ApprovalTrail

Medical device licence · 10680 · Class 3

CARDIO REP SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 25, 1999; ended October 31, 1999. It is in Health Canada’s archive of licences no longer in force.
Licence number
10680
Licence holder
Helena Laboratories, CorpBeaumont, TX, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 25, 1999
Ended
October 31, 1999
Devices covered
4

Devices on this licence

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

  • CARDIO REP ANALYZER
  • CARDIO REP CK ISOENXYMES KIT
  • CARDIO REP CK ISOFORMS KIT
  • CARDIO REP LD ISOENZYME PROCEDURE

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