KIT DE ADMINISTRACIÓN REZUM. - COFEPRIS Registration 1550C2020 SSA
Access comprehensive regulatory information for KIT DE ADMINISTRACIÓN REZUM. (REZUM ADMINISTRATION KIT.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1550C2020 SSA and manufactured by BOSTON SCIENTIFIC DEMÉXICO, S.A. DE C.V.. The device was registered on November 24, 2020.
This page provides complete registration details including product type (V. SURGICAL AND HEALING MATERIALS), 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.
EL KIT DEL DISPOSITIVO DE ADMINISTRACIÓNREZUM SE UTILIZA EXCLUSIVAMENTE CON ELGENERADORREZUMYENCONJUNTOFORMANEL SISTEMA REZUM, EL CUAL ESTÁ PREVISTOPARAALIVIARLOSSÍNTOMAS,OBSTRUCCIONESYREDUCIRTEJIDOPROSTÁTICOASOCIADOALAHIPERPLASIA PROSTÁTICA BENIGNA (BPH).ESTÁ INDICADO PARA VARONES CON UNVOLUMENPROSTÁTICO, 30CM3, CON 50AÑOSDE EDAD CONUNVOLUMEN PROSTÁTICO; 30CM3 PERO; 80 CM3.
THE REZUM ADMINISTRATION DEVICE KIT IS USED EXCLUSIVELY WITH THE REZUMY GENERATOR TOGETHER TO FORM THE REZUM SYSTEM, WHICH IS INTENDED TO RELIEVE SYMPTOMS, OBSTRUCTIONS, AND REDUCE PROSTATIC TISSUE ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH). IT IS INDICATED FOR MEN WITH A PROSTATIC VOLUME, 30CM3, WITH 50 YEARS OF AGE WITH A PROSTATIC VOLUME; 30CM3 BUT; 80 CM3.