MedtechSourcebook

GN Hearing Care Corporation

Contract manufacturer ยท Shakopee, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
2182204 (openFDA record; or search FDA's registration database)
FEI number
2182204
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
GN Hearing A/S (FDA owner/operator no. 2182204)
Registered address
5005 Dean Lakes Blvd, Shakopee, MN 55379
Contract listings
1 device listings, 1 product codes, first listed Apr 11, 2023
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterClass IIEar, nose and throatContract manufacturingApr 11, 2023