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STAT PROFILE PRIME PLUS®ANALYZER - COFEPRIS Registration 2217E2021 SSA

Access comprehensive regulatory information for STAT PROFILE PRIME PLUS®ANALYZER (STAT PROFILE PRIME PLUS®ANALYZER) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2217E2021 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
2217E2021 SSA
STAT PROFILE PRIME PLUS®ANALYZER
COFEPRIS Analysis ID: 2217E2021 SSA
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Product Use / Uso del Producto
Spanish

TERLAANNSALIZADOR STAT PROFILE PRIME PLUSESTÁ INDICADO PARA SU USO PORPROFESIONALESDELASALUDENENTORNOSDELABORATORIOCLÍNICOYPARASUUSOENEL PUNTO DE ATENCIÓN PARA LADETERMINACIÓN CUANTITATIVA DE: PH,PRESIÓNPARCIALDEDIÓXIDODECARBONO,PRESIÓN PARCIAL DE OXÍGENO,HEMATOCRITO, SODIO, POTASIO, CLORURO,CALCIO IONIZADO, IONIZADO MAGNESIO,GLUCOSA,LACTATO,CREATININA,NITRÓGENOUREICO EN SANGRE, SATURACIÓN DEOXÍGENO, HEMOGLOBINA TOTAL,OXIHEMOGLOBINA, CARBOXIHEMOGLOBINA,

English

TERLAANNSALIZADOR STAT PROFILE PRIME PLUS IS INDICATED FOR USE BY HEALTHCARE PROFESSIONALS IN CLINICAL LABORATORY SETTINGS AND FOR POINT-OF-CARE USE FOR THE QUANTITATIVE DETERMINATION OF: PH, CARBON DIOXIDE PARTIAL PRESSURE, PARTIAL PRESSURE OF OXYGEN, HEMATOCRIT, SODIUM, POTASSIUM, CHLORIDE, IONIZED CALCIUM, IONIZED MAGNESIUM, GLUCOSE, LACTATE, CREATININE, BLOOD UREA NITROGEN, OXYGEN SATURATION, TOTAL HEMOGLOBIN, OXYHEMOGLOBIN, CARBOXYHEMOGLOBIN,

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
ANALIZADOR DE QUÍMICA CLÍNICA.
Trade Name (English)
CLINICAL CHEMISTRY ANALYZER.
Registration Information
Analysis ID
2217E2021 SSA
Registration Date
December 27, 2021
Manufacturer / Fabricante
Name (English)
ASESORES MÉDICOBIOLÓGICOS, S.A. DEC.V.