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EPLEX INSTRUMENT - COFEPRIS Registration 1361E2020 SSA

Access comprehensive regulatory information for EPLEX INSTRUMENT (EPLEX INSTRUMENT) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1361E2020 SSA and manufactured by KABLA COMERCIAL, S.A. DEC.V.. The device was registered on October 08, 2020.

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
1361E2020 SSA
EPLEX INSTRUMENT
COFEPRIS Analysis ID: 1361E2020 SSA
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Product Use / Uso del Producto
Spanish

EL INSTRUMENTO EPLEX ES UN DISPOSITIVOAUTOMATIZADO DE DIAGNÓSTICO IN VITRO(IVD) DISEÑADO PARA REALIZAR PRUEBASMULTIPLEXADASDEÁCIDONUCLEICOPARALADETECCIÓNEIDENTIFICACIÓNSIMULTÁNEADEOBJETIVOSDEÁCIDONUCLEICOMEDIANTEELPROCESAMIENTODECARTUCHOSDEUNSOLOUSO.

English

THE EPLEX INSTRUMENT IS AN AUTOMATED IN VITRO DIAGNOSTIC (IVD) DEVICE DESIGNED TO PERFORM MULTIPLEXED NUCLEIC ACID TESTS FOR THE SIMULTANEOUS DETECTION AND IDENTIFICATION OF NUCLEIC ACID TARGETS BY PROCESSING SINGLE-USE CARTRIDGES.

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 PROCESAR PRUEBASDE DIAGNÓSTICO MOLECULAR
Trade Name (English)
EQUIPMENT FOR PROCESSING MOLECULAR DIAGNOSTIC TESTS
Registration Information
Analysis ID
1361E2020 SSA
Registration Date
October 08, 2020
Manufacturer / Fabricante
Name (English)
KABBALAH COMMERCIAL, S.A. DEC.V.