Customers and certificates

GN ReSound (Malaysia) Sdn Bhd

Business Sector:
Software, Active rehabilitation devices and active protheses, Electronic design
Reference No.:
546934
Certified according to :
Scope:

Contract Manufacturing of hearing aid, fitting programming application software, air conduction hearing aids and accessories (only: Labelling, pick and pack, Storage and distribution) - BRA, JPN, USA (a,b,c,d) REPs FEI No.: F002500

Certified according to :

EN ISO 13485:2016 / A11:2021

This certification belongs to the parent company 521831 GN ReSound (Malaysia) Sdn Bhd

Scope:

Manufacturing of hearing aid fitting/programming application software, air conduction hearing aids and accessories (only: Labelling, Packing, storage and distribution) and distribution air conduction hearing aids, tinnitus maskers, ear moulds, transducer modules with receiver in the ear, hearing aid face plates, self-fitting air conduction hearing aid, chargers, hearing aid fitting/programming application software, hearing aid batteries, hearing aid domes, wax guards, sport locks, acoustic tubes, audio multimedia devices, remote controls, programming interface.

Certified according to :

ISO 13485:2016

This certification belongs to the parent company 521831 GN ReSound (Malaysia) Sdn Bhd

Scope:

Manufacturing of hearing aid fitting/programming application software, air conduction hearing aids and accessories (only: labelling, pick and pack, storage and distribution) and distribution air conduction hearing aids, tinnitus maskers, ear moulds, transducer modules with receiver in the ear, hearing aid face plates, self-fitting air conduction hearing aids, chargers, hearing aid fitting/programming application software, hearing aid batteries, hearing aid domes, wax guard, sport locks, acoustic tubes, audio multimedia devices, remote controls, programming interface.