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HDL/LDL-CHOLESTEROL CALIB. (D LDL/HDL CAL) - COFEPRIS Registration 2026R2018 SSA

Access comprehensive regulatory information for HDL/LDL-CHOLESTEROL CALIB. (D LDL/HDL CAL) (HDL/LDL-CHOLESTEROL CALIB. (D LDL/HDL CAL)) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2026R2018 SSA and manufactured by SOLUCIÓN INTEGRAL A SUS NECESIDADES REGULATORIAS, S.A. DE C.V.. The device was registered on August 16, 2018.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), 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
2026R2018 SSA
HDL/LDL-CHOLESTEROL CALIB. (D LDL/HDL CAL)
COFEPRIS Analysis ID: 2026R2018 SSA
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Product Use / Uso del Producto
Spanish

ESTE PRODUCTO ESTÁ DESTINADO PARA USO IN VITRO, EN LA CALIBRACIÓN DE LOS MÉTODOS DE ELIMINACIÓN DE COLESTEROL RANDOX HDL Y LDL.

English

THIS PRODUCT IS INTENDED FOR IN VITRO USE, IN THE CALIBRATION OF RANDOX HDL AND LDL CHOLESTEROL REMOVAL METHODS.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
CALIBRADOR
Trade Name (English)
CALIBRADOR
Registration Information
Analysis ID
2026R2018 SSA
Registration Date
August 16, 2018
Manufacturer / Fabricante
Name (English)
INTEGRAL SOLUTION TO YOUR REGULATORY NEEDS, S.A. DE C.V.