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CELLSHEATH - COFEPRIS Registration 2104R2019 SSA

Access comprehensive regulatory information for CELLSHEATH (CELLSHEATH) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2104R2019 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on November 07, 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
2104R2019 SSA
CELLSHEATH
COFEPRIS Analysis ID: 2104R2019 SSA
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Product Use / Uso del Producto
Spanish

CELLSHEATH (EN COMBINACIÓN CON EL DILUYENTE ESPECIFICADO) ES UN REACTIVO PARA ANALIZAR LOS NÚMEROS Y TAMAÑOS DE LOS ERITROCITOS Y LAS PLAQUETAS MEDIANTE EL MÉTODO DE ENFOQUE HIDRODINÁMICO (DETECCIÓN CC).

English

CELLSHEATH (IN COMBINATION WITH THE SPECIFIED DILUENT) IS A REAGENT FOR ANALYZING THE NUMBERS AND SIZES OF ERYTHROCYTES AND PLATELETS USING THE HYDRODYNAMIC APPROACH METHOD (CC DETECTION).

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 DILUYENTE
Trade Name (English)
DILUENT REAGENT
Registration Information
Analysis ID
2104R2019 SSA
Registration Date
November 07, 2019
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.