Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2430101

FEI Number

2430101

Entity Name

WS Audiology USA, Inc.

City/State/Country

Hauppauge, NY, US

Establishment Address

185 Commerce Dr, Hauppauge, NY 11788, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WS Audiology USA, Inc. (Owner Number: 2430101)

Owner / Operator Contact Address

185 Commerce Dr, Hauppauge, NY 11788, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Evoke Widex Enjoy Moment Widex Evoke Enjoy Magnify Widex Magnify Widex Moment Moment Magnify Evoke Enjoy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2014-03-14
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	1992-07-01

Official Correspondent

Isabel Restivo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WS Audiology USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019918054	WS Audiology Mexico S.A. de C.V.	Tijuana Baja California, MX
3003426343	SIVANTOS PTE LTD	Singapore South East, SG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3026390997	AURELIYM GMBH	Bad Neuenahr-Ahrweiler Rhineland-Palatinate, DE
3002808415	Unitron Hearing, a division of National Hearing Services Inc.	KITCHENER Ontario, CA
3005019184	Sivantos GmbH	Erlangen Bavaria, DE
3004929038	Sonova Hearing (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2182204	GN Hearing Care Corporation	Shakopee, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2430101. Last updated year: 2026. Please use registration number 2430101 when referencing this establishment in official correspondence.