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SISTEMA BPAP RESMART GII - COFEPRIS Registration 609E2018 SSA

Access comprehensive regulatory information for SISTEMA BPAP RESMART GII (SISTEMA BPAP RESMART GII) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 609E2018 SSA and manufactured by AGUILAR MURGUรA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.. The device was registered on March 01, 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
609E2018 SSA
SISTEMA BPAP RESMART GII
COFEPRIS Analysis ID: 609E2018 SSA
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Product Use / Uso del Producto
Spanish

USADO PARA BRINDAR VENTILACIร“N NO-INVASIVA PARA PACIENTES CON APNEA OBSTRUCTIVA DEL SUEร‘O (AOS) Y/O INSUFICIENCIA RESPIRATORIA. DISEร‘ADO PARA SU USO EN PACIENTES ADULTOS EN UN ENTORNO HOSPITALARIO O EN EL HOGAR.

English

USED TO PROVIDE NON-INVASIVE VENTILATION FOR PATIENTS WITH OBSTRUCTIVE SLEEP APNEA (OSA) AND/OR RESPIRATORY FAILURE. DESIGNED FOR USE IN ADULT PATIENTS IN A HOSPITAL SETTING OR AT HOME.

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)
EQUIPO BI-NIVEL DE PRESIร“N Aร‰REA POSITIVA
Trade Name (English)
BI-LEVEL POSITIVE AIR PRESSURE EQUIPMENT
Registration Information
Analysis ID
609E2018 SSA
Registration Date
March 01, 2018
Manufacturer / Fabricante
Name (English)
AGUILAR MURGUรA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.