Data / Medical devices / Mexico / Demant Operations, S.a. De C.v.

Demant Operations, S.a. De C.v.: FDA-registered device maker in Tijuana Baja California, Mexico, 1 510(k) clearance

Name: Demant Operations, S.a. De C.v. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Demant Operations, S.a. De C.v. is registered with the FDA (registration 3017441596) in Tijuana Baja California, Mexico. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017441596
Address: Boulevard Corredor Tijuana-Rosarito 2000, #24702 H-1 Ejido Francisco Villa, Tijuana Baja California, Mexico, 22235
Owner or operator: DEMANT A/S (8010048)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: January 9, 1995
Registered through: 2026
Brand names listed: AGXO A, AGXO B, AGXO E, AGXO F, AGXO G, AGXO G S, Aligo, AudigyFit 2 and more

Devices it lists

Device	Product code	Class	Role	Source
Face Plate Hearing Aid	LRB	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Manufacturer, 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
March 18, 2014	K133308	TINNITUS SOUNDSUPPORT	KLW	Substantially Equivalent	Oticon A/S	accessdata.fda.gov

Compare with other makers

Updated March 18, 2014. 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.