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HEMOCUE® HB 301 ANALYZER - COFEPRIS Registration 409E2019 SSA

Access comprehensive regulatory information for HEMOCUE® HB 301 ANALYZER (HEMOCUE® HB 301 ANALYZER) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 409E2019 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on February 28, 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
409E2019 SSA
HEMOCUE® HB 301 ANALYZER
COFEPRIS Analysis ID: 409E2019 SSA
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Product Use / Uso del Producto
Spanish

EL DESEMPEÑO ESENCIAL DE HEMOCUE® HB 301 ANALYZER ES LA DETERMINACIÓN CUANTITATIVA DE LA HEMOGLOBINA EN SANGRE ENTERA CAPILAR, VENOSA O ARTERIAL, DEBE SER UTILIZADO SÓLO CON LAS HEMOCUE HB 301 MICROCUVETTES. EL SISTEMA ESTÁ DISEÑADO PARA USARSE EN LOS

English

THE ESSENTIAL PERFORMANCE OF HEMOCUE HB 301 ANALYZER IS THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN IN CAPILLARY, VENOUS OR ARTERIAL WHOLE BLOOD, IT SHOULD BE USED ONLY WITH HEMOCUE® HB 301 MICROCUVETTES. THE SYSTEM IS DESIGNED FOR USE IN

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
EQUIPO PARA LA DETERMINACIÓN CUANTITATIVA DE HEMOGLOBINA EN SANGRE ENTERA CAPILAR, VENOSA O ARTERIAL
Trade Name (English)
EQUIPMENT FOR THE QUANTITATIVE DETERMINATION OF HEMOGLOBIN IN CAPILLARY, VENOUS OR ARTERIAL WHOLE BLOOD
Registration Information
Analysis ID
409E2019 SSA
Registration Date
February 28, 2019
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.