ApprovalTrail

Medical device licence · 95040 · Class 3

E-CUBE 5

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed April 24, 2015; ended September 7, 2018. It is in Health Canada’s archive of licences no longer in force.
Licence number
95040
Licence holder
Alpinion Medical Systems Co., Ltd.Seoul, South Korea
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 24, 2015
Ended
September 7, 2018
Devices covered
4

Devices on this licence

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

  • E-CUBE 5 DIAGNOSTIC ULTRASOUND SYSTEM- CONVEX ARRAY TRANSDUCER
  • E-CUBE 5 DIAGNOSTIC ULTRASOUND SYSTEM- ENDO-VAGINAL ARRAY TRANSDUCER
  • E-CUBE 5 DIAGNOSTIC ULTRASOUND SYSTEM- LINEAR ARRAY TRANSDUCER
  • E-CUBE 5 DIAGNOSTIC ULTRASOUND SYSTEM- MAIN UNIT

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