Data / Medical devices / Mexico / WS Audiology Mexico S.A. de C.V.

WS Audiology Mexico S.A. de C.V.: FDA-registered device maker in Tijuana Baja California, Mexico, 1 510(k) clearance

Name: WS Audiology Mexico S.A. de C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

WS Audiology Mexico S.A. de C.V. is registered with the FDA (registration 3019918054) in Tijuana Baja California, Mexico. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 12, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3019918054
Address: Calle Todos Los Santos #9201 Col. Parque Industrial Pacifico II, Tijuana Baja California, Mexico, CP 22644
Owner or operator: WS Audiology USA, Inc. (9050836)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: April 19, 2002
Registered through: 2026
Brand names listed: ALLURE, CONNEXX, Enjoy, Evoke, Intuis 3, Intuis 4, Magnify, Moment and more

Devices it lists

Device	Product code	Class	Role	Source
Audiometer	EWO	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Prescription	QDD	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 12, 2022	K220403	Vibe SF Self-Fitting Hearing Aid	QDD	Substantially Equivalent	Wsaud A/S	accessdata.fda.gov

Compare with other makers

Updated August 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.