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MASCARILLAS DREAMWEAR - COFEPRIS Registration 2233E2018 SSA

Access comprehensive regulatory information for MASCARILLAS DREAMWEAR (DREAMWEAR MASKS) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 2233E2018 SSA and manufactured by PHILIPS Mร‰XICO COMMERCIAL, S.A. DE C.V.. The device was registered on September 24, 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
2233E2018 SSA
MASCARILLAS DREAMWEAR
COFEPRIS Analysis ID: 2233E2018 SSA
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Product Use / Uso del Producto
Spanish

LAS MASCARILLAS DREAMWEAR ESTรN DISEร‘ADAS PARA UTILIZARSE COMO INTERFAZ EN LA APLICACIร“N DE LA TERAPIA CPAP O BINIVEL A LOS PACIENTES. ESTA MASCARILLA ESTร DESTINADA PARA SU USO EXCLUSIVO DE UN SOLO PACIENTE EN UN ENTORNO DOMร‰STICO Y PARA VARIOS USOS EN M

English

DREAMWEAR MASKS ARE DESIGNED TO BE USED AS AN INTERFACE IN THE APPLICATION OF CPAP OR BILEVEL THERAPY TO PATIENTS. THIS MASK IS INTENDED FOR SINGLE-PATIENT USE ONLY IN A HOME ENVIRONMENT AND FOR VARIOUS USES IN A HOME ENVIRONMENT.

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)
MASCARILLAS
Trade Name (English)
MASKS
Registration Information
Analysis ID
2233E2018 SSA
Registration Date
September 24, 2018
Manufacturer / Fabricante
Name (English)
PHILIPS Mร‰XICO COMMERCIAL, S.A. DE C.V.