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PKL CREATININA - JAFFE - COFEPRIS Registration 523R2022 SSA

Access comprehensive regulatory information for PKL CREATININA - JAFFE (PKL CREATININE - JAFFE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 523R2022 SSA and manufactured by AXMILAB, S.A. DE C.V.. The device was registered on June 22, 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
523R2022 SSA
PKL CREATININA - JAFFE
COFEPRIS Analysis ID: 523R2022 SSA
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Product Use / Uso del Producto
Spanish

PARA LA DETERMINACIร“N CUANTITATIVA IN VITRO DECREATININA EN SUERO, PLASMA U ORINA. AGENTE DEDIAGNร“STICO IN VITRO PARA USO EXCLUSIVO DELABORATORIO CLรNICO O DE GABINETE.

English

FOR QUANTITATIVE IN VITRO DETERMINATION OF CREATININE IN SERUM, PLASMA OR URINE. IN VITRO DIAGNOSTIC AGENT FOR CLINICAL LABORATORY OR CABINET USE ONLY.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA PARA DETERMINARCREATININA
Trade Name (English)
CREATININE TEST
Registration Information
Analysis ID
523R2022 SSA
Registration Date
June 22, 2022
Manufacturer / Fabricante
Name (Spanish)
AXMILAB, S.A. DE C.V.
Name (English)
AXMILAB, S.A. DE C.V.