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INFRASCANNER MODEL 2000 SYSTEM - COFEPRIS Registration 150E2019 SSA

Access comprehensive regulatory information for INFRASCANNER MODEL 2000 SYSTEM (INFRASCANNER MODEL 2000 SYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 150E2019 SSA and manufactured by INSUMOS PARA LA SALUD, S.A. DE C.V.. The device was registered on January 31, 2019.

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
150E2019 SSA
INFRASCANNER MODEL 2000 SYSTEM
COFEPRIS Analysis ID: 150E2019 SSA
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Product Use / Uso del Producto
Spanish

EL INFRASCANNER MODEL 2000 SYSTEM ESTร INDICADO PARA LA DETECCIร“N DE HEMATOMAS SUPRATENTORIALES TRAUMรTICOS DE MรS DE 3.5 ML DE VOLUMEN A MENOS DE 2.5 CM DE LA SUPERFICIE DEL CEREBRO

English

THE INFRASCANNER MODEL 2000 SYSTEM IS INDICATED FOR THE DETECTION OF TRAUMATIC SUPRATENTORIAL HEMATOMAS OF MORE THAN 3.5 ML IN VOLUME LESS THAN 2.5 CM FROM THE SURFACE OF THE BRAIN

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO Mร‰DICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
DETECTOR PORTรTIL DE HEMATOMAS CEREBRALES CON INFRARROJO CERCANO
Trade Name (English)
PORTABLE NEAR-INFRARED BRAIN HEMATOMAS DETECTOR
Registration Information
Analysis ID
150E2019 SSA
Registration Date
January 31, 2019
Manufacturer / Fabricante
Name (English)
INSUMOS PARA LA SALUD, S.A. DE C.V.