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SISTEMA ENDOFAST RELIANT™ - COFEPRIS Registration 2021C2018 SSA

Access comprehensive regulatory information for SISTEMA ENDOFAST RELIANT™ (ENDOFAST RELIANT™ SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 2021C2018 SSA and manufactured by LEVBETH MEDICAL, S.A. DE C.V.. The device was registered on August 15, 2018.

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
2021C2018 SSA
SISTEMA ENDOFAST RELIANT™
COFEPRIS Analysis ID: 2021C2018 SSA
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Product Use / Uso del Producto
Spanish

SISTEMA ENDOFAST RELIANT™, ESTÁ INDICADO PARA LA FIJACIÓN DE MALLA QUIRÚRGICA A TEJIDOS PARA EL REFUERZO DEL TEJIDO DURANTE PROCEDIMIENTOS MÍNIMAMENTE INVASIVOS, ASÍ COMO PARA REPARACIÓN QUIRÚRGICA DEL PROLAPSO DE ÓRGANO PÉLVICO ANTERIOR O POSTERIOR.

English

ENDOFAST RELINT™ SYSTEM IS INDICATED FOR THE FIXATION OF SURGICAL MESH TO TISSUES FOR TISSUE REINFORCEMENT DURING MINIMALLY INVASIVE PROCEDURES, AS WELL AS FOR SURGICAL REPAIR OF ANTERIOR OR POSTERIOR PELVIC ORGAN PROLAPSE.

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)
SISTEMA DE FIJACIÓN CON MALLA QUIRÚRGICA
Trade Name (English)
FIXATION SYSTEM WITH SURGICAL MESH
Registration Information
Analysis ID
2021C2018 SSA
Registration Date
August 15, 2018
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL, S.A. DE C.V.