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ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723® GX TOSOH. - COFEPRIS Registration 111E2019 SSA

Access comprehensive regulatory information for ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723® GX TOSOH. (AUTOMATED GLYCOSYLATED HEMOGLOBIN ANALYZER HLC-723® GX TOSOH.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 111E2019 SSA and manufactured by SOLUCIÓN INTEGRAL A SUS NECESIDADES REGULATORIAS, S.A. DE C.V.. The device was registered on January 29, 2019.

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 I
111E2019 SSA
ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723® GX TOSOH.
COFEPRIS Analysis ID: 111E2019 SSA
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Product Use / Uso del Producto
Spanish

EL HLC-723GX ESTÁ DESTINADO AL USO DE DIAGNÓSTICO IN VITRO PARA LA DETERMINACIÓN DEL PORCENTAJE CUANTITATIVO DE HEMOGLOBINA A1C (HBA1C) EN MUESTRAS DE SANGRE TOTAL, EN EL TRATAMIENTO CLÍNICO DE LA DIABETES PARA EVALUAR LA EFICACIA A LARGO PLAZO DEL CONTRO

English

THE HLC-723GX IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE DETERMINATION OF THE QUANTITATIVE PERCENTAGE OF HEMOGLOBIN A1C (HBA1C) IN WHOLE BLOOD SAMPLES, IN THE CLINICAL MANAGEMENT OF DIABETES TO EVALUATE THE LONG-TERM EFFICACY OF THE CONTROL

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA.
Trade Name (English)
AUTOMATED GLYCOSYLATED HEMOGLOBIN ANALYZER.
Registration Information
Analysis ID
111E2019 SSA
Registration Date
January 29, 2019
Manufacturer / Fabricante
Name (English)
INTEGRAL SOLUTION TO YOUR REGULATORY NEEDS, S.A. DE C.V.