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VITESSETM - COFEPRIS Registration 636E2019 SSA

Access comprehensive regulatory information for VITESSETM (VITESSETM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 636E2019 SSA and manufactured by BAUSCH & LOMB MÉXICO, S.A. DE C.V.. The device was registered on March 27, 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
636E2019 SSA
VITESSETM
COFEPRIS Analysis ID: 636E2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA VITESSETM ESTÁ INDICADO PARA SU USO CON EL SISTEMA DE MEJORA DE LA VISIÓN STELLARIS ELITETM PARA LA CIRUGÍA DE VITRECTOMÍA DEL SEGMENTO POSTERIOR DEL OJO. VITESSETM DEBE SER UTILIZADO POR UN CIRUJANO PARA RETIRAR EFECTIVAMENTE EL HUMOR VÍTREO,

English

THE VITESSETM SYSTEM IS INDICATED FOR USE WITH THE STELLARIS ELITETM VISION ENHANCEMENT SYSTEM FOR VITRECTOMY SURGERY OF THE POSTERIOR SEGMENT OF THE EYE. VITESSETM SHOULD BE USED BY A SURGEON TO EFFECTIVELY REMOVE THE VITREOUS HUMOR,

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 VITRECTOMÍA PARA CIRUGÍA OFTÁLMICA.
Trade Name (English)
VITRECTOMY SYSTEM FOR OPHTHALMIC SURGERY.
Registration Information
Analysis ID
636E2019 SSA
Registration Date
March 27, 2019
Manufacturer / Fabricante
Name (English)
BAUSCH & LOMB MÉXICO, S.A. DE C.V.