Pure Global

HELIOS® - COFEPRIS Registration 1334E2019 SSA

Access comprehensive regulatory information for HELIOS® (HELIOS®) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1334E2019 SSA and manufactured by GRIFOLS MÉXICO, S.A. DE C.V.. The device was registered on July 16, 2019.

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.

Free Database
Powered by Pure Global AI
COFEPRIS Official Data
Clase I
1334E2019 SSA
HELIOS®
COFEPRIS Analysis ID: 1334E2019 SSA
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Use / Uso del Producto
Spanish

PARA UTILIZARLOS COMO AYUDA EN EL DIAGNÓSTICO DE DIFERENTES ENFERMEDADES AUTOINMUNITARIAS, JUNTO CON OTROS DATOS CLÍNICOS Y ANALÍTICOS.

English

TO USE THEM AS AN AID IN THE DIAGNOSIS OF DIFFERENT AUTOIMMUNE DISEASES, ALONG WITH OTHER CLINICAL AND ANALYTICAL DATA.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
PROCESADOR AUTOMATIZADO DE INMUNOFLUORESCENCIA
Trade Name (English)
AUTOMATED IMMUNOFLUORESCENCE PROCESSOR
Registration Information
Analysis ID
1334E2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
GRIFOLS MÉXICO, S.A. DE C.V.