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HYDROCLEANSE™ SINUS WASHDELIVERY SYSTEM - COFEPRIS Registration 1645E2020 SSA

Access comprehensive regulatory information for HYDROCLEANSE™ SINUS WASHDELIVERY SYSTEM (HYDROCLEANSE™ SINUS WASHDELIVERY SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1645E2020 SSA and manufactured by MEDTRONIC, S. DE R.L. DE C.V.. The device was registered on December 14, 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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COFEPRIS Official Data
Clase II
1645E2020 SSA
HYDROCLEANSE™ SINUS WASHDELIVERY SYSTEM
COFEPRIS Analysis ID: 1645E2020 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA HYDROCLEANSETM SINUS WASHDELIVERY SYSTEM ESTÁ DISEÑADO PARAIRRIGAR Y SUCCIONAR LOS SENOSPARANASALES. CONSTA DE TRESCOMPONENTES PRINCIPALES: • PUNTAS DECATÉTER DE SUCCIÓN: TRES VARIACIONES DEÁNGULO (13°, 70°, 120°) • SISTEMA DE MANIJAIRRIGADORA: INCLUYE UN CATÉTER DEIRRIGACIÓN CON UNA BOQUILLA ROCIADORAGIRATORIA, UNA RUEDA MARCADORA PARAARTICULAR LA BOQUILLA ROCIADORA Y UNCONECTORDESUCCIÓN QUESECONECTAALALÍNEADESUCCIÓNESTÁNDAR •SISTEMADE

English

THE HYDROCLEANSETM SINUS WASHDELIVERY SYSTEM IS DESIGNED TO IRRIGATE AND SUCTION THE SINUSES. IT CONSISTS OF THREE MAIN COMPONENTS: • SUCTION CATHETER TIPS: THREE ANGLE VARIATIONS (13°, 70°, 120°) • AIRRIGATOR SYSTEM: INCLUDES AN IRRIGATION CATHETER WITH A ROTATING SPRAY NOZZLE, A MARKER WHEEL TO ARTICULATE THE SPRAY NOZZLE AND A SUCTION CONNECTOR THAT CONNECTS TO THE STANDARD SUCTION LINE •

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
EQUIPO DE LAVADO NASAL
Trade Name (English)
NASAL WASH EQUIPMENT
Registration Information
Analysis ID
1645E2020 SSA
Registration Date
December 14, 2020
Manufacturer / Fabricante
Name (English)
MEDTRONIC, S. DE R.L. DE C.V.