Mexico COFEPRIS registration 99E2019 SSA

CERA-STAT® 4000

EN: CERA-STAT® 4000
Mexico flagMexico·Clase I·I. MEDICAL EQUIPMENT·DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.·Registered January 28, 2019
Product Use / Uso del Producto
Spanish

ANALIZADOR PARA MEDIR LA CONCENTRACIÓN DE HEMOGLOBINA (HBA1C) Y PROTEÍNA C REACTIVA (PCR) EN MUESTRAS DE SANGRE, SUERO O PLASMA POR ESPECTROFOTOMETRÍA DE REFLECTANCIA.

English

ANALYZER TO MEASURE THE CONCENTRATION OF HEMOGLOBIN (HBA1C) AND C-REACTIVE PROTEIN (CRP) IN BLOOD, SERUM OR PLASMA SAMPLES BY REFLECTANCE SPECTROPHOTOMETRY.

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 HEMOGLOBINA HBA1C Y PCR
Trade Name (English)
HBA1C HEMOGLOBIN ANALYZER AND PCR
Registration information
Analysis ID
99E2019 SSA
Registration Date
January 28, 2019
Manufacturer / Fabricante
Name (English)
DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.
About this record

Access comprehensive regulatory information for CERA-STAT® 4000 (CERA-STAT® 4000) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 99E2019 SSA and manufactured by DISTRIBUIDORA QUÍMICA INTEGRAL, S.A. DE C.V.. The device was registered on January 28, 2019.

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.

Free DatabasePowered by Pure Global AICOFEPRIS Official DataClase I