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PROSTATINET. - COFEPRIS Registration 1911R2018 SSA

Access comprehensive regulatory information for PROSTATINET. (PROSTATINET.) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1911R2018 SSA and manufactured by AMUNET, 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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COFEPRIS Official Data
Clase I
1911R2018 SSA
PROSTATINET.
COFEPRIS Analysis ID: 1911R2018 SSA
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Product Use / Uso del Producto
Spanish

ENSAYO INMUNOCROMATOGRÁFICO DE FLUJO LATERAL CON INTERPRETACIÓN VISUAL, QUE PERMITE LA DETECCIÓN CUALITATIVA DE ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) EN SUERO, PLASMA Y SANGRE HUMANOS. DISEÑADA COMO AUXILIAR EN LA DETECCIÓN DE CONCENTRACIONES DE PSA POR AR

English

LATERAL FLOW IMMUNOCHROMATOGRAPHIC ASSAY WITH VISUAL INTERPRETATION, WHICH ALLOWS THE QUALITATIVE DETECTION OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, PLASMA AND BLOOD. DESIGNED AS AN AID IN THE DETECTION OF PSA CONCENTRATIONS BY AR

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 EN CARTUCHO PARA LA DETECCIÓN CUALITATIVA DE ANTÍGENO PROSTÁTICO EN SUERO, PLASMA Y SA
Trade Name (English)
RAPID CARTRIDGE TEST FOR QUALITATIVE DETECTION OF PROSTATE ANTIGEN IN SERUM, PLASMA AND AS
Registration Information
Analysis ID
1911R2018 SSA
Registration Date
August 06, 2018
Manufacturer / Fabricante
Name (Spanish)
AMUNET, S.A. DE C.V.
Name (English)
AMUNET, S.A. DE C.V.