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HUMAN CHORIONICGONADOTROPHIN (HCG)DIAGNOSTIC TEST DEVICE - COFEPRIS Registration 1085R2021 SSA

Access comprehensive regulatory information for HUMAN CHORIONICGONADOTROPHIN (HCG)DIAGNOSTIC TEST DEVICE (HUMAN CHORIONICGONADOTROPHIN (HCG)DIAGNOSTIC 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 1085R2021 SSA and manufactured by DIINSEL, S.A. DE C.V.. The device was registered on May 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
1085R2021 SSA
HUMAN CHORIONICGONADOTROPHIN (HCG)DIAGNOSTIC TEST DEVICE
COFEPRIS Analysis ID: 1085R2021 SSA
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Product Use / Uso del Producto
Spanish

ELDISPOSITIVODEPRUEBARÁPIDADEHCG(ORINA), ES UN INMUNOENSAYO VISUAL,PARA LA DETECCIÓN CUALITATIVA YPRESUNTIVA DE GONADOTROPINACORIÓNICA HUMANA EN MUESTRAS DEORINA HUMANA, PARA LA DETECCIÓNTEMPRANA DEL EMBARAZO. AGENTE DEDIAGNÓSTICO IN VITRO, PARA USOEXCLUSIVO EN LABORATORIOS CLÍNICOS ODE GABINETE.

English

THE RAPID HCG (URINE) TEST DEVICE IS A VISUAL IMMUNOASSAY FOR THE QUALITATIVE AND PRESUMPTIVE DETECTION OF HUMAN GONADOTROPINACORIONICS IN HUMAN URINE SAMPLES FOR THE EARLY DETECTION OF PREGNANCY. IN VITRO DIAGNOSTIC AGENT, FOR EXCLUSIVE USE IN CLINICAL LABORATORIES OR CABINET.

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)
PRUEBA RÁPIDA DE EMBARAZO
Trade Name (English)
RAPID PREGNANCY TEST
Registration Information
Analysis ID
1085R2021 SSA
Registration Date
May 07, 2021
Manufacturer / Fabricante
Name (Spanish)
DIINSEL, S.A. DE C.V.
Name (English)
DIINSEL, S.A. DE C.V.