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STEALTH STATION S8 SYSTEM ENT SOFTWARE - COFEPRIS Registration 247E2019 SSA

Access comprehensive regulatory information for STEALTH STATION S8 SYSTEM ENT SOFTWARE (STEALTH STATION S8 SYSTEM ENT SOFTWARE) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 247E2019 SSA and manufactured by MEDTRONIC, S. DE R.L. DE C.V.. The device was registered on February 12, 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
247E2019 SSA
STEALTH STATION S8 SYSTEM ENT SOFTWARE
COFEPRIS Analysis ID: 247E2019 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA STEALTH STATIONยฎ S8 ENT SOFTWARE (OTORRINO), ESTร DESTINADO A AYUDAR A LOCALIZAR ESTRUCTURAS ANATร“MICAS EN PROCEDIMIENTOS ENT (OรDO, NARIZ Y GARGANTA) ABIERTOS O PERCUTรNEOS; TRANSESFENOIDALES, PROCEDIMIENTOS INTRANASALES, PROCEDIMIENTOS DE DES

English

THE STEALTH STATIONยฎ S8 ENT SOFTWARE (OTORRINO) SYSTEM IS INTENDED TO HELP LOCATE ANATOMICAL STRUCTURES IN OPEN OR PERCUTANEOUS ENT (EAR, NOSE AND THROAT) PROCEDURES; TRANSSPHENOIDAL, INTRANASAL PROCEDURES, DES PROCEDURES

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO Mร‰DICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE CIRUGรA GUIADA POR IMAGEN
Trade Name (English)
IMAGE-GUIDED SURGERY SYSTEM
Registration Information
Analysis ID
247E2019 SSA
Registration Date
February 12, 2019
Manufacturer / Fabricante
Name (English)
MEDTRONIC, S. DE R.L. DE C.V.