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GN Hearing A/S

DK-MF-000009536 · Denmark · Ballerup

GN Hearing A/S is registered in the European database on medical devices as a manufacturer, with 684 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa684

Most frequent device types declared: RIE, ITC, ITE, BTE, FSW.

Among these devices, 652 are declared active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryGN Hearing A/S (DK) · FDA 3005650109
Devices in EUDAMED684
Country of registrationDenmark

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