GENERADOR REZUM - COFEPRIS Registration 49E2021 SSA
Access comprehensive regulatory information for GENERADOR REZUM (REZUM GENERATOR) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 49E2021 SSA and manufactured by BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.. The device was registered on January 22, 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.
EL GENERADOR REZUM SE UTILIZAEXCLUSIVAMENTE CON EL KIT DELDISPOSITIVO DE ADMINISTRACIÓN REZUM YENCONJUNTOFORMANELSISTEMAREZUMEL CUAL ESTÁPREVISTO PARAALIVIAR LOSSÍNTOMAS, OBSTRUCCIONES Y REDUCIRTEJIDO PROSTÁTICO ASOCIADO CONHIPERPLASIA PROSTÁTICA BENIGNA (BPH).ESTÁ INDICADA PARA HOMBRES CON UNVOLUMEN PROSTÁTICO DE 30 CM3, PARAHOMBRESCON 50AÑOSDEEDADCONUNVOLUMEN PROSTÁTICO 30 CM3 PERO 80 CM3.
THE REZUM GENERATOR IS USED EXCLUSIVELY WITH THE REZUM ADMINISTRATION DEVICE KIT AND TOGETHER FORMS THE REZUMEL SYSTEM WHICH IS INTENDED TO RELIEVE SYMPTOMS, OBSTRUCTIONS AND REDUCE PROSTATE TISSUE ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH). IT IS INDICATED FOR MEN WITH A PROSTATE VOLUME OF 30 CM3, FOR MEN WITH 50 YEARS OF AGE WITH A PROSTATE VOLUME 30 CM3 BUT 80 CM3.