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DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE - COFEPRIS Registration 1109R2021 SSA

Access comprehensive regulatory information for DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE (DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1109R2021 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on December 07, 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
1109R2021 SSA
DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE
COFEPRIS Analysis ID: 1109R2021 SSA
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Product Use / Uso del Producto
Spanish

EL DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE, ES UNINMUNOENSAYO VISUAL RÁPIDO PARA LADETECCIÓN CUALITATIVA Y PRESUNTIVA DEHEMOGLOBINA HUMANA EN MUESTRASFECALES HUMANAS.ESTE DISPOSITIVO ESTÁDISEÑADO PARA UTILIZARSE COMO UNAAYUDAENELDIAGNÓSTICODEPATOLOGÍASGASTROINTESTINALES INFERIORES (G.I).

English

THE DIINSEL FECAL OCCULT BLOODDIAGNOSTIC TEST DEVICE, IS A RAPID VISUAL IMMUNOASSAY FOR THE QUALITATIVE AND PRESUMPTIVE DETECTION OF HUMAN HEMOGLOBIN IN HUMAN FECAL SAMPLES. THIS DEVICE IS DESIGNED TO BE USED AS AN AID IN THE DIAGNOSIS OF LOWER GASTROINTESTINAL (IG) PATHOLOGIES.

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)
PRUEBADIAGNÓSTICADESANGREOCULTAEN HECES
Trade Name (English)
DIAGNOSTIC TESTOCCULT bloodin FECES
Registration Information
Analysis ID
1109R2021 SSA
Registration Date
December 07, 2021
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.