Mexico COFEPRIS registration 599C2021 SSA

TACTRA

EN: TACTRA
Mexico flagMexico·Clase III·II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS·BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.·Registered June 04, 2021
Product Use / Uso del Producto
Spanish

EL DISPOSITIVO TACTRA ESTÁ DISEÑADOPARAOFRECERRIGIDEZYMALEABILIDADALPENE, Y PUEDE COLOCARSE EN POSICIÓNERECTA U OCULTA. LA PRÓTESIS DE PENETACTRAES UN IMPLANTE ESTÉRIL Y DEUNSOLOUSO,DESTINADOALTRATAMIENTODELADISFUNCIÓNERÉCTILORGÁNICACRÓNICA(IMPOTENCIA) EN HOMBRES ADULTOSCONSIDERADOS APTOS PARA LAIMPLANTACIÓN QUIRÚRGICA.

English

THE TACTRA DEVICE IS DESIGNED TO OFFER RIGIDITY AND MALLEABILITY TO THE PENIS, AND CAN BE PLACED IN AN ERECT OR CONCEALED POSITION. THE PENETACTRA PROSTHESIS IS A STERILE, SINGLE-USE IMPLANT INTENDED FOR THE TREATMENT OF CHRONIC ORGANIC ERECTILE DYSFUNCTION (IMPOTENCE) IN ADULT MEN CONSIDERED SUITABLE FOR SURGICAL IMPLANTATION.

Device classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
II. PROTESIS, ÓRTESIS Y AYUDAS FUNCIONALES
Product Type (English)
II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS
Trade Name (Spanish)
PRÓTESIS PENIANA MALEABLE
Trade Name (English)
MLEABLE PENILE PROSTHESIS
Registration information
Analysis ID
599C2021 SSA
Registration Date
June 04, 2021
Manufacturer / Fabricante
Name (English)
BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.
About this record

Access comprehensive regulatory information for TACTRA (TACTRA) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 599C2021 SSA and manufactured by BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.. The device was registered on June 04, 2021.

This page provides complete registration details including product type (II. PROSTHETICS, ORTHOSES AND FUNCTIONAL AIDS), 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.

Free DatabasePowered by Pure Global AICOFEPRIS Official DataClase III