Mexico COFEPRIS registration 1907R2018 SSA

HEALGEN PREGNANCY ONE STEP RAPID TEST STRIP

EN: HEALGEN PREGNANCY ONE STEP RAPID TEST STRIP
Mexico flagMexico·Clase I·III. DIAGNOSTIC AGENTS·MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.·Registered August 06, 2018
Product Use / Uso del Producto
Spanish

LA PRUEBA RÁPIDA DE EMBARAZO DE UN SOLO PASO (ORINA) ES UNA CROMATOGRAFÍA RÁPIDA INMUNOENSAYO PARA LA DETECCIÓN CUALITATIVA DE GONADOTROPINA CORIÓNICA HUMANA EN ORINA PARA AYUDAR A LA DETECCIÓN TEMPRANA DEL EMBARAZO.

English

THE RAPID ONE-STEP (URINE) PREGNANCY TEST IS A RAPID CHROMATOGRAPHY IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HUMAN CHORIONIC GONADOTROPIN IN URINE TO AID IN THE EARLY DETECTION OF PREGNANCY.

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 PARA DETERMINAR GONADOTROPINA CORIÓNICA HUMANA
Trade Name (English)
TEST TO DETERMINE HUMAN CHORIONIC GONADOTROPIN
Registration information
Analysis ID
1907R2018 SSA
Registration Date
August 06, 2018
Manufacturer / Fabricante
Name (English)
MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.
About this record

Access comprehensive regulatory information for HEALGEN PREGNANCY ONE STEP RAPID TEST STRIP (HEALGEN PREGNANCY ONE STEP RAPID TEST STRIP) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1907R2018 SSA and manufactured by MANDALA MÉXICO LEGAL AFFAIRS, S.A. DE C.V.. The device was registered on August 06, 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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