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UF-CALIBRATOR - COFEPRIS Registration 1175R2018 SSA

Access comprehensive regulatory information for UF-CALIBRATOR (UF-CALIBRATOR) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1175R2018 SSA and manufactured by SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.. The device was registered on May 23, 2018.

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
1175R2018 SSA
UF-CALIBRATOR
COFEPRIS Analysis ID: 1175R2018 SSA
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Product Use / Uso del Producto
Spanish

UF-CALIBRATOR SE UTILIZA PARA AJUSTAR O VERIFICAR LA SENSIBILIDAD DE LOS ANALIZADORES AUTOMATIZADOS DE PARTÍCULAS DE ORINA Y OTROS LÍQUIDOS CORPORALES DE SYSMEX, EN RELACIÓN CON LAS SIGUIENTES CONDICIONES: A) CUANDO EL CONTROL DE CALIDAD INDICA ALGÚN CAMB

English

UF-CALIBRATOR IS USED TO ADJUST OR VERIFY THE SENSITIVITY OF SYSMEX'S AUTOMATED URINE PARTICLE AND OTHER BODY FLUID ANALYZERS, IN RELATION TO THE FOLLOWING CONDITIONS: A) WHEN QUALITY CONTROL INDICATES ANY CHANGES

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)
CALIBRADOR PARA ANALIZADORES AUTOMATIZADOS DE PARTÍCULAS DE ORINA Y OTROS LÍQUIDOS CORPORALES
Trade Name (English)
CALIBRATOR FOR AUTOMATED ANALYZERS OF URINE PARTICLES AND OTHER BODY FLUIDS
Registration Information
Analysis ID
1175R2018 SSA
Registration Date
May 23, 2018
Manufacturer / Fabricante
Name (English)
SYSMEX DIAGNÓSTICOS MÉXICO, S. DE R.L. DE C.V.