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ELECTRODOS AVISTA MRI. - COFEPRIS Registration 561E2021 SSA

Access comprehensive regulatory information for ELECTRODOS AVISTA MRI. (ELECTRODOS AVISTA MRI.) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 561E2021 SSA and manufactured by BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.. The device was registered on March 30, 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 III
561E2021 SSA
ELECTRODOS AVISTA MRI.
COFEPRIS Analysis ID: 561E2021 SSA
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Product Use / Uso del Producto
Spanish

LOS ELECTRODOS AVISTA MRI ESTÁNINDICADOSPARASUUSOCONELSISTEMADEESTIMULACIÓNDEMÉDULAESPINAL(“EME”/SPINAL CORD STIMULATION “SCS”)“PRECISION”DEBOSTONSCIENTIFIC,PARAELMANEJODELDOLORCRÓNICOINTRATABLE,MEDIANTE LAESTIMULACIÓN ELÉCTRICADELASESTRUCTURASNERVIOSASENELPLANODORSAL DE LA MÉDULA ESPINAL PARAINHIBIR LA SENSACIÓN DE DOLOR.

English

THE AVISTA MRI ELECTRODES ARE INDICATED FOR USE WITH BOSTONSCIENTIFIC'S "SPINAL CORD STIMULATION (SCS""PRECISION) SYSTEM FOR THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN, BY ELECTRICAL STIMULATION OF NERVE STRUCTURES IN THE SPINAL CORD PLANODORAL TO INHIBIT PAIN SENSATION.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
ELECTRODO DEL NEUROESTIMULADORELÉCTRICO TRANSCUTÁNEO.
Trade Name (English)
ELECTRODE OF THE TRANSCUTANEOUS ELECTRICAL NEUROSTIMULATOR.
Registration Information
Analysis ID
561E2021 SSA
Registration Date
March 30, 2021
Manufacturer / Fabricante
Name (English)
BOSTONSCIENTIFICDEMÉXICO, S.A. DE C.V.