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COBAS U-601 URINE ANALYZER - ANALIZADOR DE ORINAS- ROCHE® - INVIMA Registration ccedeb911f21397d9a58675dacac11ba

Access comprehensive regulatory information for COBAS U-601 URINE ANALYZER - ANALIZADOR DE ORINAS- ROCHE® ( COBAS U-601 URINE ANALYZER - URINE ANALYZER - ROCHE®) in the Colombia medical device market through Pure Global AI's free database. This IIa medical device is registered under INVIMA analysis ID ccedeb911f21397d9a58675dacac11ba and manufactured by ROCHE DIAGNOSTICS GMBH. The device was registered on January 17, 2034.

This page provides complete registration details including product type (SURGICAL DOCTOR), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
IIa
ccedeb911f21397d9a58675dacac11ba
COBAS U-601 URINE ANALYZER - ANALIZADOR DE ORINAS- ROCHE®
INVIMA Analysis ID: ccedeb911f21397d9a58675dacac11ba
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Product Use / Uso del Producto
Spanish

EL ANALIZADOR DE ORINA COBAS U 601 (DENOMINADO ANALIZADOR DE ORINAS DE MANERA GENÉRICA) ES UN SISTEMA DE ANÁLISIS DE ORINA TOTALMENTE AUTOMATIZADO DISEÑADO PARA LA DETERMINACIÓN CUALITATIVA O SEMICUANTITATIVA IN VITRO DE ANALITOS URINARIOS, TALES COMO PH, LEUCOCITOS, NITRITOS, PROTEÍNAS, GLUCOSA, CETONAS, UROBILINÓGENO, BILIRRUBINA Y ERITROCITOS, ASÍ COMO LA DENSIDAD ESPECÍFICA, EL COLOR Y LA TURBIDEZ. ESTAS MEDICIONES SON ÚTILES EN LA EVALUACIÓN DE TRASTORNOS RENALES, URINARIOS, HEPÁTICOS Y METABÓLICOS. ESTE SISTEMA ESTÁ DESTINADO A SER UTILIZADO POR OPERADORES CUALIFICADOS EN LABORATORIOS CLÍNICOS._x000D_ EL ANALIZADOR PUEDE PROCESAR HASTA 240 MUESTRAS POR HORA. ES AUTOMATIZADO.

English

THE COBAS U 601 URINE ANALYZER (GENERICALLY REFERRED TO AS A URINE ANALYZER) IS A FULLY AUTOMATED URINALYSIS SYSTEM DESIGNED FOR THE QUALITATIVE OR SEMI-QUANTITATIVE IN VITRO DETERMINATION OF URINARY ANALYTES, SUCH AS PH, LEUKOCYTES, NITRITES, PROTEINS, GLUCOSE, KETONES, UROBILINOGEN, BILIRUBIN AND ERYTHROCYTES, AS WELL AS SPECIFIC DENSITY, COLOR AND TURBIDITY. THESE MEASUREMENTS ARE USEFUL IN THE EVALUATION OF KIDNEY, URINARY, HEPATIC AND METABOLIC DISORDERS. THIS SYSTEM IS INTENDED FOR USE BY QUALIFIED OPERATORS IN LABORATORIES CLÍNICOS._x000D_ THE ANALYZER CAN PROCESS UP TO 240 SAMPLES PER HOUR. IT'S AUTOMATED.

Device Classification
Risk Class / Clase de Riesgo
IIa
Product Type (Spanish)
MEDICO QUIRURGICOS
Product Type (English)
SURGICAL DOCTOR
Registration Information
Analysis ID
ccedeb911f21397d9a58675dacac11ba
Expire Date
January 17, 2034
Authorized Company / Fabricante
Name (English)
ROCHE DIAGNOSTICS GMBH