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HC5L-CONTROL - COFEPRIS Registration 397R2019 SSA

Access comprehensive regulatory information for HC5L-CONTROL (HC5L-CONTROL) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 397R2019 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on February 28, 2019.

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
397R2019 SSA
HC5L-CONTROL
COFEPRIS Analysis ID: 397R2019 SSA
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Product Use / Uso del Producto
Spanish

HC5L-CONTROL ES UN MATERIAL DE CONTROL SANGUÍNEO CON VALORES META Y ESTÁ DISEÑADO PARA COMPROBAR LA EXACTITUD Y PRECISIÓN DEL HUMACOUNT 5L, PARA LA DIFERENCIACIÓN EN 5 PARTES DE LOS GLÓBULOS BLANCOS.

English

HC5L-CONTROL IS A BLOOD CONTROL MATERIAL WITH TARGET VALUES AND IS DESIGNED TO CHECK THE ACCURACY AND PRECISION OF HUMACOUNT 5L, FOR DIFFERENTIATION INTO 5 PARTS OF WHITE BLOOD CELLS.

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)
CONTROL HEMATOLÓGICO CON VALORES META
Trade Name (English)
HAEMATOLOGICAL CONTROL WITH TARGET VALUES
Registration Information
Analysis ID
397R2019 SSA
Registration Date
February 28, 2019
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.