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MACRODUCT® SWEAT-CHEK™ - COFEPRIS Registration 244E2022 SSA

Access comprehensive regulatory information for MACRODUCT® SWEAT-CHEK™ (MACRODUCT® SWEAT-CHEK™) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 244E2022 SSA and manufactured by ABALAT, S.A. DE C.V.. The device was registered on March 23, 2022.

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
244E2022 SSA
MACRODUCT® SWEAT-CHEK™
COFEPRIS Analysis ID: 244E2022 SSA
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Product Use / Uso del Producto
Spanish

ELSISTEMA DERECOLECCIÓN DESUDORMACRODUCT®SWEAT-CHEK™ESTÁDISEÑADOÚNICAMENTEPARAUSOENLABORATORIOCLÍNICOPORPARTEDEPERSONALMÉDICOCALIFICADO PARA ESTIMULACIÓN Y RECOLECCIÓN DESUDOR DE HUMANOS PARA ANÁLISIS PARA ELDIAGNÓSTICO DE FIBROSIS QUÍSTICA.

English

THE SWEAT-CHEK™MACRODUCT®SWEAT COLLECTION SYSTEM IS DESIGNED SOLELY FOR CLINICAL LABORATORY USE BY QUALIFIED MEDICAL PERSONNEL FOR STIMULATION AND COLLECTION OF HUMAN SWEAT FOR ANALYSIS FOR THE DIAGNOSIS OF CYSTIC FIBROSIS.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA PARA PRUEBA DESUDOR
Trade Name (English)
SWEAT TEST SYSTEM
Registration Information
Analysis ID
244E2022 SSA
Registration Date
March 23, 2022
Manufacturer / Fabricante
Name (Spanish)
ABALAT, S.A. DE C.V.
Name (English)
ABALAT, S.A. DE C.V.