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SIFILINET - COFEPRIS Registration 736R2019 SSA

Access comprehensive regulatory information for SIFILINET (SIFILINET) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 736R2019 SSA and manufactured by AMUNET, S.A. DE C.V.. The device was registered on April 09, 2019.

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 II
736R2019 SSA
SIFILINET
COFEPRIS Analysis ID: 736R2019 SSA
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Product Use / Uso del Producto
Spanish

ES UNA PRUEBA RรPIDA BASADA EN INMUNOCROMATOGRAFรA DE FLUJO LATERAL CON INTERPRETACIร“N VISUAL, QUE DETECTA CUALITATIVAMENTE ANTICUERPOS CONTRA TREPONEMA PALLIDUM, EN SUERO/PLASMA/SANGRE TOTAL. AGENTE DE DIAGNร“STICO PARA USO IN VITRO. PARA USO EXCLUSIVO

English

IT IS A RAPID TEST BASED ON LATERAL FLOW IMMUNOCHROMATOGRAPHY WITH VISUAL INTERPRETATION, WHICH QUALITATIVELY DETECTS ANTIBODIES AGAINST TREPONEMA PALLIDUM, IN SERUM/PLASMA/WHOLE BLOOD. DIAGNOSTIC AGENT FOR IN VITRO USE. FOR EXCLUSIVE USE

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA RรPIDA EN CARTUCHO PARA LA DETECCIร“N CUALITATIVA DE ANTICUERPOS CONTRA TREPONEMA PALLIDUM EN
Trade Name (English)
RAPID CARTRIDGE TEST FOR QUALITATIVE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM IN
Registration Information
Analysis ID
736R2019 SSA
Registration Date
April 09, 2019
Manufacturer / Fabricante
Name (Spanish)
AMUNET, S.A. DE C.V.
Name (English)
AMUNET, S.A. DE C.V.