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VALLEYLAB™ FX8 - COFEPRIS Registration 801E2018 SSA

Access comprehensive regulatory information for VALLEYLAB™ FX8 (VALLEYLAB™ FX8) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 801E2018 SSA and manufactured by KENDALL DE MÉXICO, S.A. DE C.V.. The device was registered on March 22, 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
801E2018 SSA
VALLEYLAB™ FX8
COFEPRIS Analysis ID: 801E2018 SSA
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Product Use / Uso del Producto
Spanish

LA PLATAFORMA DE ENERGÍA VALLEYLAB FX8 ES UN GENERADOR ELECTROQUIRÚRGICO DE ALTA FRECUENCIA DISEÑADO PARA USARSE CON ACCESORIOS MONOPOLARES Y BIPOLARES PARA CORTE Y COAGULACIÓN DE TEJIDO.

English

THE VALLEYLAB FX8 ENERGY PLATFORM IS A HIGH-FREQUENCY ELECTROSURGICAL GENERATOR DESIGNED FOR USE WITH MONOPOLAR AND BIPOLAR FITTINGS FOR TISSUE CUTTING AND COAGULATION.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
GENERADOR PARA ELECTROCIRUGÍA
Trade Name (English)
GENERATOR FOR ELECTROSURGERY
Registration Information
Analysis ID
801E2018 SSA
Registration Date
March 22, 2018
Manufacturer / Fabricante
Name (English)
KENDALL DE MÉXICO, S.A. DE C.V.