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CREATININE2 - COFEPRIS Registration 0820R2022 SSA

Access comprehensive regulatory information for CREATININE2 (CREATININE2) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 0820R2022 SSA and manufactured by ABBOTTLABORATORIES DEMÉXICO, S.A. DE C.V.. The device was registered on August 19, 2022.

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
0820R2022 SSA
CREATININE2
COFEPRIS Analysis ID: 0820R2022 SSA
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Product Use / Uso del Producto
Spanish

EL ENSAYO CREATININE2 SE UTILIZA PARA LADETERMINACIÓNCUANTITATIVADECREATININAENSUERO,PLASMA U ORINA HUMANOS EN ARCHITECT C SYSTEMS.AGENTEDEDIAGNÓSTICOPARAUSOINVITRO.PARAUSOEXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETES

English

THE CREATININE2 ASSAY IS USED FOR THE QUANTITATIVE DETERMINATION OF CREATININE IN HUMAN SERUM, PLASMA OR URINE AT ARCHITECT C SYSTEMS. DIAGNOSTIC AGENTFOR use. FOR USE ONLY IN CLINICAL LABORATORIES OR CABINETS

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)
ENSAYO PARA LADETERMINACIÓN CUANTITATIVA DE CREATININA
Trade Name (English)
ASSAY FOR THE QUANTITATIVE DETERMINATION OF CREATININE
Registration Information
Analysis ID
0820R2022 SSA
Registration Date
August 19, 2022
Manufacturer / Fabricante
Name (English)
ABBOTTLABORATORIES DE MÉXICO, S.A. DE C.V.