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POCH-PACK™ - COFEPRIS Registration 2230R2019 SSA

Access comprehensive regulatory information for POCH-PACK™ (POCH-PACK™) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2230R2019 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on December 06, 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
2230R2019 SSA
POCH-PACK™
COFEPRIS Analysis ID: 2230R2019 SSA
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Product Use / Uso del Producto
Spanish

EL POCH-PACK D Y POCH-PACK L SON REACTIVOS QUE DILUYEN Y LISAN LOS ERITROCITOS PARA LA DETERMINACIÓN EXACTA DEL CONTEO DE LEUCOCITOS, PARA EL ANÁLISIS TRIMODAL DE LA DISTRIBUCIÓN DEL TAMAÑO DE LEUCOCITOS Y MEDICIÓN DEL NIVEL DE HEMOGLOBINA. EL REACTIVO ES

English

POCH-PACK D AND POCH-PACK L ARE REAGENTS THAT DILUTE AND LYSE ERYTHROCYTES FOR ACCURATE DETERMINATION OF LEUKOCYTE COUNT, TRIMODAL ANALYSIS OF LEUKOCYTE SIZE DISTRIBUTION AND MEASUREMENT OF HAEMOGLOBIN LEVEL. THE REAGENT IS

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)
REACTIVO PARA LA LISIS DE GLÓBULOS ROJOS.
Trade Name (English)
REAGENT FOR LYSIS OF RED BLOOD CELLS.
Registration Information
Analysis ID
2230R2019 SSA
Registration Date
December 06, 2019
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.