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ENDOPRÓTESIS SOLARIS - COFEPRIS Registration 1436C2019 SSA

Access comprehensive regulatory information for ENDOPRÓTESIS SOLARIS (SOLARIS STENT) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 1436C2019 SSA and manufactured by LEVBETH MEDICAL S.A. DE C.V.. The device was registered on July 25, 2019.

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
1436C2019 SSA
ENDOPRÓTESIS SOLARIS
COFEPRIS Analysis ID: 1436C2019 SSA
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Product Use / Uso del Producto
Spanish

PARA SER UTILIZADO EN EL SISTEMA VASCULAR(EXCEPTO VASOS DEL SISTEMA CIRCULATORIO CENTRAL Y DEL SISTEMA NERVIOSO CENTRAL) PARA TRATAR LA REESTENOSIS O LAS REOCLUSIONES, DISECCIONES, ESTENOSIS RESIDUAL CON PERFUSIÓN DEFICIENTE DESPUÉS DE LA DILATACIÓN DE BA

English

TO BE USED IN THE VASCULAR SYSTEM (EXCEPT VESSELS OF THE CENTRAL CIRCULATORY SYSTEM AND CENTRAL NERVOUS SYSTEM) TO TREAT RESTENOSIS OR RHEOCLUSIONS, DISSECTIONS, RESIDUAL STENOSIS WITH POOR PERFUSION AFTER BAC DILATION

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)
STENT VASCULAR PERIFÉRICO
Trade Name (English)
PERIPHERAL VASCULAR STENT
Registration Information
Analysis ID
1436C2019 SSA
Registration Date
July 25, 2019
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL S.A. DE C.V.