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STATSTRIPSTATSTRIPXPRESSGLU-TESTSTRIPS/STATSTRIPSTATSTRIPXPRESS GLU CONTROLS - COFEPRIS Registration 2215R2021 SSA

Access comprehensive regulatory information for STATSTRIPSTATSTRIPXPRESSGLU-TESTSTRIPS/STATSTRIPSTATSTRIPXPRESS GLU CONTROLS (STATSTRIPSTATSTRIPXPRESSGLU-TESTSTRIPS/STATSTRIPSTATSTRIPXPRESS GLU CONTROLS) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2215R2021 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 (III. DIAGNOSTIC AGENTS), 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
2215R2021 SSA
STATSTRIPSTATSTRIPXPRESSGLU-TESTSTRIPS/STATSTRIPSTATSTRIPXPRESS GLU CONTROLS
COFEPRIS Analysis ID: 2215R2021 SSA
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Product Use / Uso del Producto
Spanish

STATSTRIP STATSTRIP XPRESS GLU- TESTSTRIPS ESTÁN DISEÑADAS PARA LADETERMINACIÓNCUANTITATIVADEGLUCOSAENMUESTRASDEPUNCIÓNCAPILAR ENELDEDO, SANGRE ENTERA VENOSA, SANGRETOTAL ARTERIAL, SANGRE TOTAL ARTERIALNEONATAL Y ESPECÍMENES POR PUNCIÓNDEL TALÓN NEONATAL, EN TODO ELHOSPITAL Y EN TODOS LOS ENTORNOS DEATENCIÓNMÉDICAPROFESIONAL,INCLUIDOSLOSPACIENTESQUERECIBENINTERVENCIÓN/ TERAPIA MÉDICA INTENSIVA. LAS TIRASREACTIVAS DE GLUCOSA STATSTRIP SEUTILIZAN ÚNICAMENTE CON LA FAM

English

STATSTRIP STATSTRIP XPRESS GLU- TESTSTRIPS ARE DESIGNED FOR THE QUANTITATIVE DETERMINATION OF GLUCOSE IN FINGER CAPILLARY PUNCTURE, VENOUS WHOLE BLOOD, ARTERIAL WHOLE BLOOD, NEONATAL ARTERIAL WHOLE BLOOD AND NEONATAL HEEL PUNCTURE SPECIMENS, THROUGHOUT THE HOSPITAL AND IN ALL PROFESSIONAL HEALTHCARE SETTINGS, INCLUDING PATIENTS RECEIVING INTERVENTION/INTENSIVE MEDICAL THERAPY. STATSTRIP GLUCOSE TIRASREACTIVE DRUGS ARE USED ONLY WITH FAM

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNÓSTICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
TIRADEPRUEBAYSOLUCIÓNDECONTROLDE GLUCOSA.
Trade Name (English)
TIRADETESTANDGLUCOSE control solution.
Registration Information
Analysis ID
2215R2021 SSA
Registration Date
December 27, 2021
Manufacturer / Fabricante
Name (English)
ASESORES MÉDICOBIOLÓGICOS, S.A. DEC.V.