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HOT AXIOS™ BOSTON SCIENTIFIC. - COFEPRIS Registration 2543C2018 SSA

Access comprehensive regulatory information for HOT AXIOS™ BOSTON SCIENTIFIC. (HOT AXIOS™ BOSTON SCIENTIFIC.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 2543C2018 SSA and manufactured by BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.. The device was registered on November 05, 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
2543C2018 SSA
HOT AXIOS™ BOSTON SCIENTIFIC.
COFEPRIS Analysis ID: 2543C2018 SSA
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Product Use / Uso del Producto
Spanish

EL STENT Y SISTEMA INTRODUCTOR MEJORADO CON ELECTROCAUTERIZACIÓN HOT AXIOS ESTÁ INDICADO PARA FACILITAR EL DRENAJE ENDOSCÓPICO TRANSGÁSTRICO O TRANSDUODENAL DE UN SEUDOQUISTE PANCREÁTICO O UNA NECROSIS AISLADA CON ≥ 70 % DE ACUMULACIÓN DE LÍQUIDO O

English

THE HOT AXIOS ELECTROCAUTERY-ENHANCED STENT AND INTRODUCER SYSTEM IS INDICATED TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF A PANCREATIC PSEUDOCYST OR ISOLATED NECROSIS WITH ≥ 70% FLUID ACCUMULATION OR

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 Y SISTEMA INTRODUCTOR MEJORADO CON ELECTROCAUTERIZACIÓN.
Trade Name (English)
STENT AND INTRODUCER SYSTEM IMPROVED WITH ELECTROCAUTERY.
Registration Information
Analysis ID
2543C2018 SSA
Registration Date
November 05, 2018
Manufacturer / Fabricante
Name (English)
BOSTON SCIENTIFIC DE MÉXICO, S.A. DE C.V.