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Data / Medical devices / Mouthpiece, Breathing / Mexico

FDA-registered makers of Mouthpiece, Breathing in Mexico: 7 establishments

7 establishments in Mexico are registered with the FDA to make Mouthpiece, Breathing (product code BYP). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Mouthpiece, Breathing
Product code
BYP
Country
Mexico

Makers of Mouthpiece, Breathing in Mexico

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Polimeros Formula de Tecate S.A de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
S & Mohr America, S.A. DE C.V.ESTADO DE MEXICO Ciudad de Mexico, MexicoManufacturer0000api.fda.gov

Updated November 2, 2026. 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.