Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019918054

FEI Number

3019918054

Entity Name

WS Audiology Mexico S.A. de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle Todos Los Santos #9201, Col. Parque Industrial Pacifico II, Tijuana Baja California CP 22644, MX

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WS Audiology USA, Inc. (Owner Number: 9050836)

Owner / Operator Contact Address

101 Wood Avenue South, 7th Floor, Iselin, NJ 08830, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SHOEBOX Consult SHOEBOX PureTest Pure 312 AX CONNEXX Intuis 4 Motion Charge&Go Signia Pure Rexton CROS Signia Intuis Signia Silk Signia Active IX Signia IX Rexton M-Core Signia Styletto Rexton Reach Signia Active Pure Charge&Go Signia Intuis 3 Signia Insio Silk Charge&Go Signia Active Pro ALLURE Styletto IX Signia Motion Rexton Styletto AX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2024-09-12
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2011-07-12

Official Correspondent

Isabel Restivo

US Agent Details

Isabel Restivo Business: WS Audiology USA, Inc. Email: isabel.restivo@wsa.com Phone: (551) 5799581

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
2430101	WS Audiology USA, Inc.	Hauppauge, NY, US
3003426343	SIVANTOS PTE LTD	Singapore South East, SG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019918054. Last updated year: 2026. Please use registration number 3019918054 when referencing this establishment in official correspondence.