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Hearing Aid Co.

USA · Mchenry
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 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
5listed device types
Class I 4Class II 1Class III 0
plus 9 registration records and 115 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
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 States9 registration records, 115 510(k), 0 PMA, 38 excluded
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: Magnatone Hearing Aid Corp. dba Persona Medical · MAGNATONE HEARING AID CORPORATION DBA PERSONA MEDICAL · WARBLER HEARING AID INC DBA. WARBLER HEARING
Same-named companies — This database also contains companies with near-identical names: A-1 Hearing Aid Lab. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mchenry

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

21976
21977
41980
31982
51983
31985
21986
61987
101988
41989
111990
61991
31992
101993
131994
151995
61996
81997
12008
12010

FDA listed device types

Face Plate Hearing Aid 1Hearing Aid, Air-Conduction, Over The Counter 1Device, Anti-Stammering 1Hearing Aid, Air-Conduction, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK093715EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE2010-12-22
USK080955ZEN PROGRAM (MIND 440 HEARING AID)2008-06-27
USK973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,481997-11-19

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