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SIARETRON 4000 - COFEPRIS Registration 1227E2018 SSA

Access comprehensive regulatory information for SIARETRON 4000 (SIARETRON 4000) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1227E2018 SSA and manufactured by GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.. The device was registered on May 29, 2018.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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 II
1227E2018 SSA
SIARETRON 4000
COFEPRIS Analysis ID: 1227E2018 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA DE VENTILACIÓN SIARETRON 4000 SUMINISTRA VENTILACIONES CONTROLADAS O ESPONTÁNEAS CON UN NIVEL REAJUSTABLE DE LA PRESIÓN POSITIVA DE FINAL DE ESPIRACIÓN (PEEP), DE LA SENSIBILIDAD TRIGGER Y DE LA CONCENTRACIÓN DE OXÍGENO. EL VENTILADOR PULMONA

English

THE SIARETRON 4000 VENTILATION SYSTEM PROVIDES CONTROLLED OR SPONTANEOUS VENTILATION WITH A READJUSTABLE LEVEL OF POSITIVE END-EXPIRATORY PRESSURE (PEEP), TRIGGER SENSITIVITY AND OXYGEN CONCENTRATION. THE PULMONA FAN

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
VENTILADOR PULMONAR
Trade Name (English)
PULMONARY VENTILATOR
Registration Information
Analysis ID
1227E2018 SSA
Registration Date
May 29, 2018
Manufacturer / Fabricante
Name (English)
GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.