ApprovalTrail

Medical device licence · 31171 · Class 3

SOUNDTEC DIRECT SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed August 8, 2001; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
31171
Licence holder
Soundtec, Inc.Oklahoma City, OK, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 8, 2001
Ended
February 16, 2004
Devices covered
8

Devices on this licence

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

  • THE DIRECT SYSTEM - BEHIND-THE-EAR SOUND PROCESSOR
  • THE DIRECT SYSTEM - CLINICIAN'S KIT
  • THE DIRECT SYSTEM - DEEP EARMOLD IMPRESSION KIT
  • THE DIRECT SYSTEM - DEEP EARMOLD IMPRESSION REFILL KIT
  • THE DIRECT SYSTEM - EARMOLD/COIL ASSEMBLY (ECA)
  • THE DIRECT SYSTEM - SURGEON'S KIT
  • THE DIRECT SYSTEM - TITANIUM-ENCASED MAGNETS RIGHT AND LEFT
  • THE DIRECT SYSTEM - USER'S KIT

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