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CLARISCAN - COFEPRIS Registration 73R2019 SSA

Access comprehensive regulatory information for CLARISCAN (CLARISCAN) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 73R2019 SSA and manufactured by GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.. The device was registered on January 28, 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 III
73R2019 SSA
CLARISCAN
COFEPRIS Analysis ID: 73R2019 SSA
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Product Use / Uso del Producto
Spanish

CLARISCAN SOLO DEBE UTILIZARSE CUANDO SEA IMPRESCINDIBLE OBTENER INFORMACIÓN DIAGNÓSTICA QUE NO SE HAYA PODIDO OBTENER POR RESONANCIA MAGNÉTICA (RM) SIN CONTRASTE. CLARISCAN ES UN MEDIO DE CONTRASTE INDICADO PARA EL REALCE DEL CONTRASTE EN LA IMAGEN OBTE

English

CLARISCAN SHOULD ONLY BE USED WHEN IT IS ESSENTIAL TO OBTAIN DIAGNOSTIC INFORMATION THAT COULD NOT BE OBTAINED BY MAGNETIC RESONANCE IMAGING (MRI) WITHOUT CONTRAST. CLARISCAN IS A CONTRAST MEDIUM INDICATED FOR CONTRAST ENHANCEMENT IN THE IMAGE OBTAINED

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
MEDIO DE CONTRASTE
Trade Name (English)
CONTRAST MEDIUM
Registration Information
Analysis ID
73R2019 SSA
Registration Date
January 28, 2019
Manufacturer / Fabricante
Name (English)
GE SISTEMAS MÉDICOS DE MÉXICO, S.A. DE C.V.