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EMIT® 2000 GENTAMICIN PLUS CALIBRATORS - COFEPRIS Registration 310R2019 SSA

Access comprehensive regulatory information for EMIT® 2000 GENTAMICIN PLUS CALIBRATORS (EMIT® 2000 GENTAMICIN PLUS CALIBRATORS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 310R2019 SSA and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.. The device was registered on February 18, 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
310R2019 SSA
EMIT® 2000 GENTAMICIN PLUS CALIBRATORS
COFEPRIS Analysis ID: 310R2019 SSA
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Product Use / Uso del Producto
Spanish

LOS CALIBRADORES PLUS EMIT® 2000 PARA GENTAMICINA ESTÁN DISEÑADOS PARA UTILIZARLOS CON EL ANÁLISIS DE GENTAMICINA PLUS EMIT® 2000. PARA USO EXCLUSIVO DE LABORATORIO CLÍNICO O DE GABINETE. AGENTE DE DIAGNÓSTICO IN VITRO.

English

THE PLUS EMIT® 2000 CALIBRATORS FOR GENTAMICIN ARE DESIGNED FOR USE WITH GENTAMICIN PLUS EMIT® 2000 ANALYSIS. FOR CLINICAL LABORATORY OR CABINET USE ONLY. IN VITRO DIAGNOSTIC AGENT.

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)
CALIBRADOR DE GENTAMICIN PLUS
Trade Name (English)
CALIBRADOR DE GENTAMICIN PLUS
Registration Information
Analysis ID
310R2019 SSA
Registration Date
February 18, 2019
Manufacturer / Fabricante
Name (English)
SIEMENS HEALTHCARE DIAGNOSTICS, S. DE R.L. DE C.V.