Mexico COFEPRIS registration 1182E2020 SSA

CONTROLADOR DE POTENCIAELLIPSY

EN: ELLIPSY POWERHOUSE CONTROLLER
Mexico flagMexico·Clase II·I. MEDICAL EQUIPMENT·LEVBETH MEDICAL, S.A. DE C.V.·Registered September 03, 2020
Product Use / Uso del Producto
Spanish

EL SISTEMA ® MÉDICO ELLIPSYS AVENU ESTÁINDICADO PARA LA CREACIÓN DE UNAANASTOMOSIS DE LA ARTERIA RADIALPROXIMALALAVENAPERFORANTEATRAVÉSDE UN ENFOQUE DE ACCESO VENOSORETROGRADO EN PACIENTES CON UNDIÁMETRODELOSVASOSMÍNIMODE2,0MMYMENOSDE1,5MMDESEPARACIÓNENTRELAARTERIA Y LA VENA EN EL SITIO DE LACREACIÓN DE LA FÍSTULA, QUE TIENEN UNAENFERMEDADRENALCRÓNICAQUEREQUIEREDIÁLISIS.

English

THE ELLIPSYS AVENU MEDICAL SYSTEM ® IS INDICATED FOR THE CREATION OF AN ANASTOMOSIS OF THE RADIAL ARTERY PROXIMAL TO PERFORATING LAVENE THROUGH A RETROGRADE VENOUS ACCESS APPROACH IN PATIENTS WITH A MINIMUM VESSEL DIAMETER OF 2.0MM AND LESS THAN 1.5MMSEPARATION BETWEEN THE ARTERY AND VEIN AT THE SITE OF FISTULA CREATION, WHO HAVE CHRONIC KIDNEY DISEASE REQUIRING DIALYSIS.

Device classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
CONTROLADOR DE POTENCIA
Trade Name (English)
POWER CONTROLLER
Registration information
Analysis ID
1182E2020 SSA
Registration Date
September 03, 2020
Manufacturer / Fabricante
Name (English)
LEVBETH MEDICAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for CONTROLADOR DE POTENCIAELLIPSY (ELLIPSY POWERHOUSE CONTROLLER) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1182E2020 SSA and manufactured by LEVBETH MEDICAL, S.A. DE C.V.. The device was registered on September 03, 2020.

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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