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ALIGNRT PLUS - COFEPRIS Registration 548E2022 SSA

Access comprehensive regulatory information for ALIGNRT PLUS (ALIGNRT PLUS) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 548E2022 SSA and manufactured by EMERGO,S.DER.L.DE C.V.. The device was registered on July 01, 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
548E2022 SSA
ALIGNRT PLUS
COFEPRIS Analysis ID: 548E2022 SSA
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Product Use / Uso del Producto
Spanish

ALIGNRTPLUSESUNSISTEMADEIMÁGENESDESUPERFICIETRIDIMENSIONAL(3D)BASADOENVIDEO,QUESEUTILIZAPARAOBTENERIMÁGENESDELASUPERFICIEDELAPIELDEUN PACIENTE EN 3D Y PARA SEGUIR EL PATRÓN DERESPIRACIÓN DEL PACIENTE CON EL FIN DE OBTENERIMÁGENESSINCRONIZADASCONLARESPIRACIÓNDURANTEUN TRATAMIENTO DE RADIOTERAPIA

English

ALIGNRTPLUS is a video-based three-dimensional (3D) SURFACE IMAGING SYSTEM USED TO OBTAIN 3D IMAGES OF A PATIENT'S SKIN SURFACE AND TO FOLLOW THE PATIENT'S BREATHING PATTERN IN ORDER TO OBTAIN BREATH-SYNCHRONISED IMAGES DURING RADIOTHERAPY TREATMENT

Device Classification
Risk Class / Clase de Riesgo
Clase II
Product Type (Spanish)
I. EQUIPO MÉDICO
Product Type (English)
I. MEDICAL EQUIPMENT
Trade Name (Spanish)
SISTEMA DE IMÁGENES DESUPERFICIE
Trade Name (English)
SURFACE IMAGING SYSTEM
Registration Information
Analysis ID
548E2022 SSA
Registration Date
July 01, 2022
Manufacturer / Fabricante
Name (English)
EMERGO,S.DER. L.DE C.V.