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AIRMINI - COFEPRIS Registration 1382E2018 SSA

Access comprehensive regulatory information for AIRMINI (AIRMINI) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1382E2018 SSA and manufactured by AGUILAR MURGUÍA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.. The device was registered on June 05, 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
1382E2018 SSA
AIRMINI
COFEPRIS Analysis ID: 1382E2018 SSA
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Product Use / Uso del Producto
Spanish

AIRMINI (AUTOSET) ESTÁ INDICADO PARA TRATAR LA APNEA OBSTRUCTIVA DEL SUEÑO (AOS) EN PACIENTES QUE PESAN MÁS DE 30 KG (66 LIBRAS) Y PARA MUJERES CON AOS LEVE O MODERADA CUANDO SE USA EL MODO DE TRATAMIENTO AUTOSET FOR HER. ESTÁ DISEÑADO PARA USO DOMÉSTICO

English

AIRMINI (AUTOSET) IS INDICATED TO TREAT OBSTRUCTIVE SLEEP APNEA (OSA) IN PATIENTS WEIGHING MORE THAN 30 KG (66 POUNDS) AND FOR WOMEN WITH MILD OR MODERATE OSA WHEN USING THE AUTOSET FOR HER MODE OF TREATMENT. IT IS DESIGNED FOR HOME USE

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
DISPOSITIVO DE PRESIÓN AÉREA POSITIVA
Trade Name (English)
POSITIVE AIR PRESSURE DEVICE
Registration Information
Analysis ID
1382E2018 SSA
Registration Date
June 05, 2018
Manufacturer / Fabricante
Name (English)
AGUILAR MURGUÍA ASESORES EN SERVICIOS INTEGRALES DE SALUD, S.A. DE C.V.