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SISTEMA DE STENT CORONARIO SELF-APPOSING® LIBERADOR DE SIROLIMUS “XPOSITION S®” - COFEPRIS Registration 366C2018 SSA

Access comprehensive regulatory information for SISTEMA DE STENT CORONARIO SELF-APPOSING® LIBERADOR DE SIROLIMUS “XPOSITION S®” (SIROLIMUS ELUTING SELF-APPOSING® CORONARY STENT SYSTEM "XPOSITION S®") in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 366C2018 SSA and manufactured by LEVBETH MEDICAL, S.A. DE C.V.. The device was registered on February 13, 2018.

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.

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COFEPRIS Official Data
Clase III
366C2018 SSA
SISTEMA DE STENT CORONARIO SELF-APPOSING® LIBERADOR DE SIROLIMUS “XPOSITION S®”
COFEPRIS Analysis ID: 366C2018 SSA
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Product Use / Uso del Producto
Spanish

XPOSITION S ESTÁ PREVISTO PARA MEJORAR EL DIÁMETRO LUMINAL CORONARIO EN EL TRATAMIENTO DE: SÍNDROME CORONARIO AGUDO (ACS), ENFERMEDAD PRINCIPAL IZQUIERDA NO PROTEGIDA, LESIONES DE NOVO EN VASOS QUE INVOLUCRAN UNA RAMA LATERAL (BIFURCACIÓN), LESIONES DE NO

English

XPOSITION S IS PLANNED TO IMPROVE CORONARY LUMINAL DIAMETER IN THE TREATMENT OF: ACUTE CORONARY SYNDROME (ACHD), UNPROTECTED LEFT MAIN DISEASE, DE NOVO LESIONS IN VESSELS INVOLVING A LATERAL BRANCH (BIFURCATION), NO LESIONS

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)
SISTEMA DE STENT CORONARIO LIBERADOR DE SIROLIMUS
Trade Name (English)
SIROLIMUS-ELUTING CORONARY STENT SYSTEM
Registration Information
Analysis ID
366C2018 SSA
Registration Date
February 13, 2018
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL, S.A. DE C.V.