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OXALATO BIOSYSTEMS BIOSIMEX - COFEPRIS Registration 508R2021 SSA

Access comprehensive regulatory information for OXALATO BIOSYSTEMS BIOSIMEX (OXALATO BIOSYSTEMS BIOSIMEX) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 508R2021 SSA and manufactured by BIO SIMEX, S.A. DE C.V.. The device was registered on March 25, 2021.

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
508R2021 SSA
OXALATO BIOSYSTEMS BIOSIMEX
COFEPRIS Analysis ID: 508R2021 SSA
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Product Use / Uso del Producto
Spanish

INDICADOPARAMEDIRLACONCENTRACIÓNDE OXALATO EN ORINA HUMANA. LOSVALORES OBTENIDOS SON ÚTILES COMOAYUDA EN EL DIAGNÓSTICO DE LAHIPEROXALURIA.

English

INDICATED TO MEASURE THE CONCENTRATION OF OXALATE IN HUMAN URINE. THE VALUES OBTAINED ARE USEFUL AS AN AID IN THE DIAGNOSIS OF HYPEROXALURIA.

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)
KIT DE DIAGNÓSTICO IN VITRO PARAOXALATO.
Trade Name (English)
IN VITRO DIAGNOSTIC KIT PARAOXALATE.
Registration Information
Analysis ID
508R2021 SSA
Registration Date
March 25, 2021
Manufacturer / Fabricante
Name (English)
BIO SIMEX, S.A. DE C.V.