Data / Medical devices / Mexico / Starkey De Mexico, S.A. De C.V.

Starkey De Mexico, S.A. De C.V.: FDA-registered device maker in Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, Mexico, 2 510(k) clearances

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

Starkey De Mexico, S.A. De C.V. is registered with the FDA (registration 3002159143) in Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, Mexico. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 19, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002159143
Address: Calle Norte 7 Numero Lote 2 Y 3 Entre Diagonal Lorenzo De La Garza Y Poniente 2, Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, Mexico, CP 87499
Owner or operator: Starkey Laboratories, Inc. (2125608)
Roles: Manufacturer
First device listed: June 12, 2007
Registered through: 2026
Brand names listed: AMP, AMPLI-MINI E 7S, AMPLI-MINI Signature Series, AMPLI-TV 2 LE ST, AMPLITV Streamer, AUDIBEL INTRIGUE AI, AUDIGY AGXS GENESIS AI, AUDIOSYNC INTRIGUE AI and more

Devices it lists

Device	Product code	Class	Role	Source
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Manufacturer	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Manufacturer	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
June 19, 2020	K201370	Multiflex Tinnitus Technology	KLW	Substantially Equivalent	Starkey Laboratories, Inc.	accessdata.fda.gov
October 31, 2012	K122876	MULTIFLEX TINNITUS TECHNOLOGY	KLW	Substantially Equivalent	Starkey Laboratories	accessdata.fda.gov

Compare with other makers

Updated June 19, 2020. 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.