GN Hearing C-3 - Page 28

Manufacturer according to
EUMedical Device
Regulation 2017/745 and
Health Canada:
GNHearingA/S
Lautrupbjerg 7
DK-2750 Ballerup
Denmark
Manufacturer according to
FDA:
GN Hearing Care Corporation
8001 E Bloomington Freeway
Bloomington, MN 55420
USA
Any serious incident that has occurred in relation to the device should be reported to the
Legal manufacturer GNHearingA/S and the competent authority of the EU Member
State in which the user and/or patient is established.
402047011US_CA- 23.02 -Rev. B (Date of issuance:2023.02.01)