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STATSTRIP XPRESS 2 GLUCOSEMETER - COFEPRIS Registration 2220E2021 SSA

Access comprehensive regulatory information for STATSTRIP XPRESS 2 GLUCOSEMETER (STATSTRIP XPRESS 2 GLUCOSEMETER) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2220E2021 SSA and manufactured by ASESORES MÉDICOBIOLÓGICOS, S.A. DEC.V.. The device was registered on December 27, 2021.

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 I
2220E2021 SSA
STATSTRIP XPRESS 2 GLUCOSEMETER
COFEPRIS Analysis ID: 2220E2021 SSA
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Product Use / Uso del Producto
Spanish

EL DISPOSITIVO STATSTRIP XPRESS 2GLUCOSE METER ES UN SISTEMA DEMEDICIÓN HOSPITALARIA DE GLUCOSA YESTÁ DISEÑADO PARA EL DIAGNÓSTICO INVITROENELPUNTODEATENCIÓN,ENUSODE MÚLTIPLES PACIENTES PARA LADETERMINACIÓNCUANTITATIVADEGLUCOSAENLAPUNCIÓNCAPILARDELDEDO,SANGREENTERAVENOSA,SANGREENTERAARTERIAL,SANGRE ENTERA ARTERIAL NEONATAL YNEONATALENMUESTRASDEPUNCIÓNDELTALÓNENTODOELHOSPITALYENTODOSLOS ENTORNOS DE ATENCIÓN MÉDICAPROFESIONAL, INCLUIDOS LOS PACIENTES QU

English

THE STATSTRIP XPRESS 2GLUCOSE METER DEVICE IS A HOSPITAL-BASED GLUCOSE MEASUREMENT SYSTEM AND IS DESIGNED FOR POINT-OF-CARE INVITRO, MULTI-PATIENT USE FOR QUANTITATIVE DETERMINATION OF GLUCOSE IN CAPILLARY FINGER UNSOLVATION, INTRAVENOUS WHOLE BLOOD, ENTEROARTERIAL BLOOD, NEONATAL AND NEONATAL ARTERIAL WHOLE BLOOD IN HEEL PUNCTURE SAMPLES THROUGHOUT THE HOSPITAL AND IN ALL PROFESSIONAL HEALTHCARE SETTINGS, INCLUDING PATIENTS WHO

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
MEDIDOR DE GLUCOSA
Trade Name (English)
GLUCOSE METER
Registration Information
Analysis ID
2220E2021 SSA
Registration Date
December 27, 2021
Manufacturer / Fabricante
Name (English)
ASESORES MÉDICOBIOLÓGICOS, S.A. DEC.V.