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DIGITALINTRAORALIMAGINGPLATESYSTEM - COFEPRIS Registration 2047E2021 SSA

Access comprehensive regulatory information for DIGITALINTRAORALIMAGINGPLATESYSTEM (DIGITALINTRAORALIMAGINGPLATESYSTEM) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 2047E2021 SSA and manufactured by EMERGO,S.DER.L.DEC.V.. The device was registered on March 12, 2021.

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 I
2047E2021 SSA
DIGITALINTRAORALIMAGINGPLATESYSTEM
COFEPRIS Analysis ID: 2047E2021 SSA
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Product Use / Uso del Producto
Spanish

EL SISTEMA DE PLACA DE IMAGEN DIGITALINTRAORAL, MODELO F200, F210 ESTÁINDICADO PARA CAPTURAR, DIGITALIZAR YPROCESAR IMÁGENES GENERADAS POR UNEQUIPO DE RAYOS X INTRAORALESALMACENADAS EN MEDIOS DE GRABACIÓNDEPLACADEIMAGEN. ESTEPRODUCTOESTÁDISEÑADO PARASU USO EN HOSPITALES YCLÍNICAS,YDEBESEROPERADOYUTILIZADOPORPROFESIONALESCAPACITADOSCONLAGUÍA DE UN MÉDICO.

English

THE INTRAORAL DIGITAL IMAGING PLATE SYSTEM, MODEL F200, F210 IS INDICATED FOR CAPTURING, DIGITIZING AND PROCESSING IMAGES GENERATED BY INTRAORAL X-RAY EQUIPMENT STORED ON IMAGE PLATE RECORDING MEDIA. THIS PRODUCT IS DESIGNED FOR USE IN HOSPITALS AND CLINICS AND SHOULD BE OPERATED AND USED BY PROFESSIONALS TRAINED UNDER THE GUIDANCE OF A DOCTOR.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE PLACA DE IMAGEN DIGITALINTRAORAL
Trade Name (English)
INTRAORAL DIGITAL IMAGING PLATE SYSTEM
Registration Information
Analysis ID
2047E2021 SSA
Registration Date
March 12, 2021
Manufacturer / Fabricante
Name (Spanish)
EMERGO,S.DER.L.DEC.V.
Name (English)
EMERGO,S.DER. L.DEC.V.