RETEVAL - COFEPRIS Registration 1367E2021 SSA
Access comprehensive regulatory information for RETEVAL (RETEVAL) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1367E2021 SSA and manufactured by ARFAMEX, S.A. DE C.V.. The device was registered on August 09, 2021.
This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.
RETEVALESTÁINDICADOPARASUUSOENLAMEDICIÓN DE POTENCIALESELECTROFISIOLÓGICOS VISUALES,INCLUYENDOELECTRORETINOGRAMA(ERG)YPOTENCIALEVOCADOVISUAL(VEP).RETEVALTAMBIÉNESTÁINDICADOPARASUUSOENLAMEDICIÓN DEL DIÁMETRO DE LA PUPILA.RETEVALTAMBIÉNESTÁINDICADOPARALADETECCIÓNDERETINOPATÍADIABÉTICAQUEPONEENPELIGROLAVISIÓN.RETEVALESTÁDESTINADO COMO UNA AYUDA EN ELDIAGNÓSTICO Y EL MANEJO DE LAENFERMEDAD EN DISFUNCIONES DE VÍASVISUALES O TRASTORNOS OFTÁLMICOS.
RETEVAL IS INDICATED FOR USE IN THE MEASUREMENT OF VISUAL ELECTROPHYSIOLOGICAL POTENTIALS, INCLUDING ELECTRORETINOGRAM(ERG) AND VISUAL EVOKED POTENTIAL (VEP). RETEVALIS ALSO INDICATED FOR USE IN PUPIL DIAMETER MEASUREMENT. RETEVALis also indicated for the detection of vision-threatening diabetic retinopathy. RETEVAL IS INTENDED AS AN AID IN THE DIAGNOSIS AND MANAGEMENT OF DISEASE IN VISUAL PATHWAY DYSFUNCTIONS OR OPHTHALMIC DISORDERS.