Mexico COFEPRIS registration 1342R2019 SSA

UREAL

EN: UREAL
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·PRODUCTOS ROCHE, S.A. DE C.V.·Registered July 16, 2019
Product Use / Uso del Producto
Spanish

PRUEBA IN VITRO PARA LA DETERMINACIÓN CUANTITATIVA DE UREA/NITRÓGENO UREICO EN SUERO, PLASMA Y ORINA HUMANOS EN LOS SISTEMAS ROCHE. AGENTE DE DIAGNÓSTICO PARA USO IN VITRO. PARA USO EXCLUSIVO EN LABORATORIOS CLÍNICOS O DE GABINETES.

English

IN VITRO TEST FOR THE QUANTITATIVE DETERMINATION OF UREA/UREA NITROGEN IN HUMAN SERUM, PLASMA AND URINE IN ROCHE SYSTEMS. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR USE IN CLINICAL OR CABINET LABORATORIES ONLY.

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)
PRUEBA PARA LA DETERMINACIÓN DE UREA/NITRÓGENO UREICO.
Trade Name (English)
TEST FOR THE DETERMINATION OF UREA/UREA NITROGEN.
Registration information
Analysis ID
1342R2019 SSA
Registration Date
July 16, 2019
Manufacturer / Fabricante
Name (English)
PRODUCTOS ROCHE, S.A. DE C.V.
About this record

Access comprehensive regulatory information for UREAL (UREAL) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1342R2019 SSA and manufactured by PRODUCTOS ROCHE, S.A. DE C.V.. The device was registered on July 16, 2019.

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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