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FLEXMAP 3D® / LABSCAN 3D™ - COFEPRIS Registration 0996E2022 SSA

Access comprehensive regulatory information for FLEXMAP 3D® / LABSCAN 3D™ (FLEXMAP 3D® / LABSCAN 3D™) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 0996E2022 SSA and manufactured by ABALAT, S.A. DE C.V.. The device was registered on September 29, 2022.

This page provides complete registration details including product type (I. MEDICAL EQUIPMENT), 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
0996E2022 SSA
FLEXMAP 3D® / LABSCAN 3D™
COFEPRIS Analysis ID: 0996E2022 SSA
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Pricing
Product Use / Uso del Producto
Spanish

EL SISTEMA FLEXMAP 3D® / LABSCAN3D™ CON ELSOFTWARE XPONENT® ES UN SISTEMA DE PRUEBASCLÍNICASMULTIPLEXDESTINADOAMEDIRYACLASIFICARLASDISTINTASSEÑALESGENERADASENUNANÁLISISDEDIAGNÓSTICOINVITROAPARTIRDEUNAMUESTRACLÍNICA.EL INSTRUMENT

English

THE FLEXMAP 3D®/LABSCAN3D™ SYSTEM WITH XPONENT® SOFTWARE IS A MULTIPLEXED CLINICAL TESTING SYSTEM DESIGNED TO MEASURE AND CLASSIFY THE DIFFERENT SIGNALS GENERATED IN A DIAGNOSTIC ANALYSIS BY SEPARATING A CLINICAL SAMPLE.

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
INSTRUMENTOSPARASISTEMASDE PRUEBAS CLÍNICASMÚLTIPLES
Trade Name (English)
INSTRUMENTSFOR MULTIPLE CLINICAL TEST SYSTEMS
Registration Information
Analysis ID
0996E2022 SSA
Registration Date
September 29, 2022
Manufacturer / Fabricante
Name (Spanish)
ABALAT, S.A. DE C.V.
Name (English)
ABALAT, S.A. DE C.V.