ApprovalTrail

Medical device licence · 74428 · Class 3

VIBRANT SOUNDBRIDGE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed July 13, 2007. It is in Health Canada’s list of active licences.
Licence number
74428
Licence holder
Med-El Elektromedizinische Geraete GmbhInnsbruck, Austria
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 13, 2007
Devices covered
22

Devices on this licence

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

  • INCUS-LP-COUPLER LEFT
  • INCUS-LP-COUPLER RIGHT
  • INCUS-SP-COUPLER
  • INCUS-SYMPHONIX-COUPLER LEFT
  • INCUS-SYMPHONIX-COUPLER RIGHT
  • REMOTE CONTROL
  • RW-SOFT-COUPLER
  • SAMBA 2 AP UNIT
  • SAMBA 2 CLINICAL PACKAGES
  • SAMBA 2 GO
  • SAMBA 2 GO NECKLOOP
  • SAMBA 2 GO SLEEVE
  • SAMBA 2 POM
  • SAMBA 2 USER KIT
  • SAMBA AUDIO PROCESSOR
  • SAMBA BATTERY PILL
  • SAMBA PROGRAMMING CABLE
  • STAPES-SH-COUPLER
  • VORP 503 IMPLANT KIT
  • VORP 503 SIZER KIT
  • VORP. 502A RIGHT
  • VORP. 502B LEFT

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