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EXIA - COFEPRIS Registration 180C2021 SSA

Access comprehensive regulatory information for EXIA (EXIA) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 180C2021 SSA and manufactured by PROMESURGICAL, S.A.DE C.V.. The device was registered on February 09, 2021.

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.

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COFEPRIS Official Data
Clase III
180C2021 SSA
EXIA
COFEPRIS Analysis ID: 180C2021 SSA
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Product Use / Uso del Producto
Spanish

EXIAESTÁINDICADO PARAELPROLAPSODELACÚPULAVAGINALENMUJERES QUEHANTENIDO UNA HISTERECTOMÍA PREVIA(SACROCOLPOPEXIA) Y PARA EL PROLAPSODEL ÚTERO (HISTEROSACROPEXIA). ELSISTEMA RECONSTRUYE LAS ESTRUCTURASDE SOPORTE DEL SUELO PÉLVICO,REPOSICIONANDO LOS ÓRGANOS EN SUPOSICIÓN NATURAL.

English

EXIA IS INDICATED FOR PROLAPSE OF THE VAGINAL DOME IN WOMEN WHO HAVE HAD A PREVIOUS HYSTERECTOMY (SACROCOLPOPEXY) AND FOR PROLAPSE OF THE UTERUS (HYSTEROSACROPEXY). THE SYSTEM RECONSTRUCTS THE SUPPORTING STRUCTURES OF THE PELVIC FLOOR, REPOSITIONING THE ORGANS IN NATURAL SUPPOSITION.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
V. MATERIALES QUIRÚRGICOS Y DE CURACIÓN
Product Type (English)
V. SURGICAL AND HEALING MATERIALS
Trade Name (Spanish)
MALLA QUIRÚRGICA PARA EL PROLAPSO DE ÓRGANOS, PÉLVICOS, COMPUESTO DEPOLÍMEROS
Trade Name (English)
SURGICAL MESH FOR ORGAN PROLAPSE, PELVIC, POLYMER COMPOSITE
Registration Information
Analysis ID
180C2021 SSA
Registration Date
February 09, 2021
Manufacturer / Fabricante
Name (English)
PROMESURGICAL, S.A.DE C.V.