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T1 - COFEPRIS Registration 913E2021 SSA

Access comprehensive regulatory information for T1 (T1) in the Mexico medical device market through Pure Global AI's free database. This Clase III medical device is registered under COFEPRIS analysis ID 913E2021 SSA and manufactured by HIOSSEN DE MÉXICO,S.A. DE C.V.. The device was registered on May 28, 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 III
913E2021 SSA
T1
COFEPRIS Analysis ID: 913E2021 SSA
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Product Use / Uso del Producto
Spanish

ELSISTEMADEIMÁGENESRADIOGRÁFICAST1ES UN EQUIPO DE RAYOS X DIGITAL PARAPROFESIONALESDENTALESQUECONVIERTELAS SEÑALES DE RAYOS X EN SEÑALESDIGITALES PARA ADQUIRIR IMÁGENES 2D YRECONSTRUIRLASENIMÁGENES3D,USANDOTECNOLOGÍA PANORÁMICA (PANO),CEFALOMÉTRICA (CEPH), Y TOMOGRAFÍACOMPUTARIZADA(CT)PARAELDIAGNÓSTICODE LA ESTRUCTURA ANATÓMICA DEL ÁREAORALYMAXILOFACIAL.T1-CSPROPORCIONALOS TRES MODOS, MIENTRAS QUE T1-CPROPORCIONALOSDOSPRIMEROSMODOSYEXCLUYE EL MODO CEPH.

English

THE ST1RADIOGRAPHIC IMAGING SYSTEM IS A DIGITAL X-RAY MACHINE FOR DENTAL PROFESSIONALS THAT CONVERTS X-RAY SIGNALS INTO DIGITAL SIGNALS TO ACQUIRE 2D IMAGES AND RECONSTRUCT THEM INTO 3D IMAGES, USING PANORAMIC (PANO), CEPHALOMETRIC (CEPH), AND COMPUTED TOMOGRAPHY (CT) TECHNOLOGY FOR THE DIAGNOSIS OF THE ANATOMICAL STRUCTURE OF THE ORAL AND MAXILLOFACIAL AREA. T1-CSPROPORTIONAL THREE MODES, WHILE T1-CPROPORTIONOSDOSDOSMODESY EXCLUDES CEPH MODE.

Device Classification
Risk Class / Clase de Riesgo
Clase III
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE RAYOS X DENTALPANORÁMICO/TOMOGRÁFICO FIJO, DIGITAL.
Trade Name (English)
FIXED DIGITAL, PANORAMIC/TOMOGRAPHIC DENTAL X-RAY SYSTEM.
Registration Information
Analysis ID
913E2021 SSA
Registration Date
May 28, 2021
Manufacturer / Fabricante
Name (English)
HIOSSEN DE MÉXICO,S.A. DE C.V.