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REAGENT KIT FOR HEMOGLOBIN(HBA1C) KIT MINDRAY - COFEPRIS Registration 2050R2021 SSA

Access comprehensive regulatory information for REAGENT KIT FOR HEMOGLOBIN(HBA1C) KIT MINDRAY (REAGENT KIT FOR HEMOGLOBIN(HBA1C) KIT MINDRAY) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2050R2021 SSA and manufactured by MINDRAY MEDICALMÉXICO, S. DE R.L. DEC.V.. The device was registered on March 12, 2021.

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
2050R2021 SSA
REAGENT KIT FOR HEMOGLOBIN(HBA1C) KIT MINDRAY
COFEPRIS Analysis ID: 2050R2021 SSA
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Product Use / Uso del Producto
Spanish

PARALADETERMINACIÓNCUANTITATIVADELA CONCENTRACIÓN DE HBA1C EN SANGREHUMANA COMPLETA EN SISTEMASFOTOMÉTRICOS.

English

FOR THE QUANTITATIVE DETERMINATION OF THE CONCENTRATION OF HBA1C IN WHOLE HUMAN BLOOD IN PHOTOMETRIC SYSTEMS.

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)
KITREACTIVOPARALADETERMINACIÓNDEHEMOGLOBINAA1CMEDIANTEMÉTODODEENSAYO ENZIMÁTICO
Trade Name (English)
KITREAGENT for the determination of hemoglobinaA1C by ENZYMATIC assay method
Registration Information
Analysis ID
2050R2021 SSA
Registration Date
March 12, 2021
Manufacturer / Fabricante
Name (English)
MINDRAY MEDICALMÉXICO, S. DE R.L. DEC.V.