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HUMALOOP T - COFEPRIS Registration 1760E2018 SSA

Access comprehensive regulatory information for HUMALOOP T (HUMALOOP T) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1760E2018 SSA and manufactured by INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.. The device was registered on July 18, 2018.

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
1760E2018 SSA
HUMALOOP T
COFEPRIS Analysis ID: 1760E2018 SSA
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Product Use / Uso del Producto
Spanish

EL HUMALOOP ES UN INSTRUMENTO QUE SE USA PARA EL PROCESAMIENTO DE MUESTRAS DE PACIENTES HUMANOS, LA AMPLIFICACIÓN Y LA DETECCIÓN DE FLUOROSCENCIA DE ÁCIDOS NUCLEICOS, EL INSTRUMENTO PERTENECE AL EQUIPO MÉDICO IVD, QUE UTILIZA LA AMPLIFICACIÓN ISOTÉRMICA P

English

THE HUMALOOP IS AN INSTRUMENT THAT IS USED FOR THE PROCESSING OF HUMAN PATIENT SAMPLES, AMPLIFICATION AND DETECTION OF NUCLEIC ACID FLUOROSCENCE, THE INSTRUMENT BELONGS TO THE IVD MEDICAL EQUIPMENT, WHICH USES ISOTHERMAL AMPLIFICATION P

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
INSTRUMENTO PARA LA DETECCIÓN DE BACTERIAS QUE PERTENECEN AL COMPLEJO DE TUBERCULOSIS MYCOBACTERIUM
Trade Name (English)
INSTRUMENT FOR THE DETECTION OF BACTERIA BELONGING TO THE MYCOBACTERIUM TUBERCULOSIS COMPLEX
Registration Information
Analysis ID
1760E2018 SSA
Registration Date
July 18, 2018
Manufacturer / Fabricante
Name (English)
INVESTIGACIÓN DIAGNÓSTICA, S.A. DE C.V.