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OEC ONE - COFEPRIS Registration 799E2019 SSA

Access comprehensive regulatory information for OEC ONE (OEC ONE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 799E2019 SSA and manufactured by GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.. The device was registered on April 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.

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COFEPRIS Official Data
Clase II
799E2019 SSA
OEC ONE
COFEPRIS Analysis ID: 799E2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA OEC ONE ESTÁ DISEÑADO PARA PROPORCIONAR IMÁGENES DE PUNTO DIGITAL/EN PELÍCULA O FLUOROSCÓPICAS DE POBLACIONES DE PACIENTES ADULTOS Y PEDIÁTRICOS DURANTE PROCEDIMIENTOS DE DIAGNÓSTICO, INTERVENCIONISTAS Y QUIRÚRGICOS. DENTRO DE LAS APLICACIONES

English

THE OEC ONE SYSTEM IS DESIGNED TO PROVIDE DIGITAL/FILM OR FLUOROSCOPIC SPOT IMAGES OF ADULT AND PEDIATRIC PATIENT POPULATIONS DURING DIAGNOSTIC, INTERVENTIONAL AND SURGICAL PROCEDURES. INSIDE THE APPLICATIONS

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE RAYOS X CON BRAZO EN C MÓVIL
Trade Name (English)
X-RAY SYSTEM WITH MOBILE C-ARM
Registration Information
Analysis ID
799E2019 SSA
Registration Date
April 16, 2019
Manufacturer / Fabricante
Name (English)
GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.