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STELLARIS ELITE™ PC CON SISTEMA LÁSER - COFEPRIS Registration 1269E2018 SSA

Access comprehensive regulatory information for STELLARIS ELITE™ PC CON SISTEMA LÁSER (STELLARIS ELITE™ PC WITH LASER SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1269E2018 SSA and manufactured by BAUSCH & LOMB MÉXICO, S.A. DE C.V.. The device was registered on May 31, 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 II
1269E2018 SSA
STELLARIS ELITE™ PC CON SISTEMA LÁSER
COFEPRIS Analysis ID: 1269E2018 SSA
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Product Use / Uso del Producto
Spanish

INDICADO PARA LA EMULSIFICACIÓN Y EXTRACCIÓN DE CATARATAS Y PARA VITRECTOMÍAS EN INTERVENCIONES QUIRÚRGICAS DE LOS SEGMENTOS ANTERIOR Y POSTERIOR. EL SISTEMA ESTÁ DISEÑADO PARA UTILIZARSE EN INTERVENCIONES TANTO DEL SEGMENTO ANTERIOR COMO DEL POSTERIOR. P

English

INDICATED FOR THE EMULSIFICATION AND EXTRACTION OF CATARACTS AND FOR VITRECTOMIES IN SURGICAL INTERVENTIONS OF THE ANTERIOR AND POSTERIOR SEGMENTS. THE SYSTEM IS DESIGNED FOR USE IN BOTH ANTERIOR AND POSTERIOR SEGMENT INTERVENTIONS. P

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 MICROQUIRÚRGICO
Trade Name (English)
MICROSURGICAL SYSTEM
Registration Information
Analysis ID
1269E2018 SSA
Registration Date
May 31, 2018
Manufacturer / Fabricante
Name (English)
BAUSCH & LOMB MÉXICO, S.A. DE C.V.