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SISTEMA SPYGLASS DISCOVER. - COFEPRIS Registration 460E2021 SSA

Access comprehensive regulatory information for SISTEMA SPYGLASS DISCOVER. (SISTEMA SPYGLASS DISCOVER.) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 460E2021 SSA and manufactured by BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.. The device was registered on March 19, 2021.

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
460E2021 SSA
SISTEMA SPYGLASS DISCOVER.
COFEPRIS Analysis ID: 460E2021 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA DIGITAL SISTEMA SPYGLASSDISCOVERESTÁINDICADOPARASUUSOENAPLICACIONES DIAGNÓSTICAS YTERAPÉUTICAS EN INTERVENCIONESENDOSCÓPICAS DEL SISTEMAPANCREATOBILIAR, INCLUIDOS LOSCONDUCTOSHEPÁTICOS.ELSISTEMADIGITALSISTEMA SPYGLASS DISCOVER CONSTA DEDOS COMPONENTES: EL CATÉTER DIGITALSPYGLASS DISCOVER Y EL CONTROLADORDIGITAL SPYGLASS DISCOVER. EL CATÉTERDIGITAL SPYGLASS DISCOVER ESTÁ IDEADOPARAOFRECERUNAVISUALIZACIÓNDIRECTAY GUIAR DISPOSITIVOS ÓPTICOS Y

English

THE SPYGLASSDISCOVER DIGITAL SYSTEM SYSTEM IS INDICATED FOR USE IN DIAGNOSTIC AND THERAPEUTIC APPLICATIONS IN ENDOSCOPIC INTERVENTIONS OF THE PANCREATOBILIARY SYSTEM, INCLUDING HEPATIC DUCTS. THE DIGITAL SPYGLASS DISCOVER SYSTEM CONSISTS OF TWO COMPONENTS: THE DIGITALSPYGLASS DISCOVER CATHETER AND THE DIGITAL SPYGLASS DISCOVER CONTROLLER. THE SPYGLASS DISCOVER DIGITAL CATHETER IS DESIGNED TO PROVIDE DIRECT VISUALIZATION AND GUIDE OPTICAL DEVICES AND

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 VISUALIZACIÓN ENDOSCÓPICA.
Trade Name (English)
ENDOSCOPIC VISUALIZATION SYSTEM.
Registration Information
Analysis ID
460E2021 SSA
Registration Date
March 19, 2021
Manufacturer / Fabricante
Name (English)
BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.