Manufacturer according to EUMedical
Device Regulation 2017/745:
Manufacturer according to FDA: Manufacturer according to Health Canada:
GN ReSound A/S
Lautrupbjerg 7
DK-2750 Ballerup
Denmark
GN ReSound North America
8001 E Bloomington Freeway
Bloomington, MN 55420
USA
1-888-735-4327
resound.com
ReSound Canada
2 East Beaver Creek Road, Building 3
Richmond Hill, ON L4B 2N3
Canada
1-888-737-6863
resound.com
ReSound Government Services
8001 E Bloomington Freeway
Bloomington, MN 55420
USA
1-800-392-9932
resound.com/veterans
Any serious incident that has occurred in relation to the device should be reported to the Legal manufacturer GN ReSound
A/S and the competent authority of the EU Member State in which the user and/or patient is established.
401851011US_CA_VA- 23.01 - Rev. B (Date of issuance:2023.01.01)
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