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GN Hearing Care Corporation

USA · Shakopee
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 2Class II 5Class III 0
plus 16 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
51registered devices
Class II 51
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
18 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States16 registration records, 5 510(k), 0 PMA, 7 excluded
Brazil51 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: GN CONSUMER HEARING CORPORATION · GN Hearing Care Corporation · GN Hearing A/S · GN HEARING A/S
Same-named companies — This database also contains companies with near-identical names: GN CONSUMER HEARING CORPORATION, GN Hearing A/S. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Shakopee

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22018 · K180495
12020 · K193303
12022 · K213424
12026 · K254108

FDA listed device types

Self-Fitting Air-Conduction Hearing Aid, Over The Counter 1Masker, Tinnitus 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Self-Fitting Air-Conduction Hearing Aid, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Face Plate Hearing Aid 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)2026-06-25
USK213424Jabra Enhance Plus2022-01-19
USK193303Tinnitus Sound Generator Module2020-02-20
BR10293049028Família Intra-auricular Danavox KlarClass II
BR10293049029Família Intra-auricular Danavox BaraniClass II
BR10293049018Família intra-auricular ReSound ONEClass II

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