Customers and certificates

GN ReSound A/S

Business Sector:
Active non-implantable devices for ear, nose and throat, Active rehabilitation devices and active protheses, Software development (including software validation)
Reference No.:
099446
Certified according to :

Medical Devices VO (EU) 2017/745

Download certificate : 10.09.2024 englisch

Scope:

Air conduction hearing aids (RIE), tinnitus maskers MDA 0310 - Active non-implantable devices for ear, nose and throat RIE Hearing aid fitting/programming (FSW), application software MDA 0315 - Software FSW Hearing aid remote control (GAN), application software MDA 0315 - Software GAN Air conduction hearing aids (BTE), tinnitus maskers MDA 0310 - Active non-implantable devices for ear, nose and throat BTE Air conduction Hearing aids (ITC), tinnitus maskers MDA 0310 - Active non-implantable devices for ear, nose and throat ITC Air conduction hearing aids (ITE), tinnitus maskers MDA 0310 - Active non-implantable devices for ear, nose and throat ITE

Certified according to :
Scope:

The design and manufacturing of air conduction hearing aids, transducer module with receiver in the ear, tinnitus masker, hearing aid fitting/programming application software, earmoulds, hearing aid remote control application software, hearing aid domes, hearing aid batteries, programming interfaces, wax guards, sports locks, acoustic tubes, audio multimedia devices, remote controls, chargers and service of air conduction hearing aids, tinnitus masker, hearing aid fitting/programming application software, hearing aid remote control application software, hearing aid remote control application software, as used to compensate for impaired hearing.

Scope:

Design, manufacturing, service and repair of Hearing instruments, Tinnitus Devices, Software, Ear moulds, Domes and Programming Interface.