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ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723®G8 TOSOH - COFEPRIS Registration 2619E2018 SSA

Access comprehensive regulatory information for ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723®G8 TOSOH (AUTOMATED GLYCOSYLATED HEMOGLOBIN ANALYZER HLC-723®G8 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 2619E2018 SSA and manufactured by SOLUCIÓN INTEGRAL A SUS NECESIDADES REGULATORIAS, S.A. DE C.V.. The device was registered on November 13, 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 I
2619E2018 SSA
ANALIZADOR AUTOMATIZADO DE HEMOGLOBINA GLICOSILADA HLC-723®G8 TOSOH
COFEPRIS Analysis ID: 2619E2018 SSA
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Product Use / Uso del Producto
Spanish

EL HLC-723®G8 ESTÁ DESTINADO AL USO 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 CONTROL

English

HLC-723®G8 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 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
2619E2018 SSA
Registration Date
November 13, 2018
Manufacturer / Fabricante
Name (English)
INTEGRAL SOLUTION TO YOUR REGULATORY NEEDS, S.A. DE C.V.