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FACTOR IX DEFICIENT PLASMA - COFEPRIS Registration 2173R2019 SSA

Access comprehensive regulatory information for FACTOR IX DEFICIENT PLASMA (FACTOR IX DEFICIENT PLASMA) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2173R2019 SSA and manufactured by REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.. The device was registered on November 21, 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 I
2173R2019 SSA
FACTOR IX DEFICIENT PLASMA
COFEPRIS Analysis ID: 2173R2019 SSA
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Product Use / Uso del Producto
Spanish

REACTIVO PARA LA DETERMINACIÓN COAGULOMÉTRICA EN UNA ETAPA DEL FACTOR IX. PARA USO DE DIAGNÓSTICO IN VITRO. AGENTE DE DIAGNÓSTICO PARA USO EXCLUSIVO DE LABORATORIO CLÍNICO O DE GABINETE

English

REAGENT FOR COAGULOMETRIC DETERMINATION IN ONE STEP OF FACTOR IX. FOR IN VITRO DIAGNOSTIC USE. DIAGNOSTIC AGENT FOR CLINICAL LABORATORY OR CABINET USE ONLY

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)
REACTIVO PARA LA DETERMINACIÓN DEL FACTOR IX
Trade Name (English)
REAGENT FOR THE DETERMINATION OF FACTOR IX
Registration Information
Analysis ID
2173R2019 SSA
Registration Date
November 21, 2019
Manufacturer / Fabricante
Name (English)
REPRESENTACIONES LABIN MÉXICO, S.A. DE C.V.