RETCAM ENVISION™ - COFEPRIS Registration 1920E2021 SSA
Access comprehensive regulatory information for RETCAM ENVISION™ (RETCAM ENVISION™) in the Mexico medical device market through Pure Global AI's free database. This Clase II medical device is registered under COFEPRIS analysis ID 1920E2021 SSA and manufactured by ARFAMEX, S.A. DE C.V.. The device was registered on November 22, 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.
RETCAMENVISIONTMESUTILIZADOPARA: -OBTENCIÓNDEIMÁGENESOFTALMOLÓGICASGENERAL, INCLUYENDO IMÁGENESRETINIANAS,CORNEALESYEXTERNAS. -FOTODOCUMENTACIÓN DE ENFERMEDADESOCULARES PEDIÁTRICAS, INCLUYENDORETINOPATÍA DEL PREMATURO (RP). -EXÁMENES PARA LA DETECCIÓN DERETINOPATÍA DEL PREMATURO (RP)PREUMBRALTIPO2(ZONA1,ESTADIO1O2,SIN PATOLOGÍA ADICIONAL, O ZONA 2,ESTADIO3,SINPATOLOGÍAADICIONAL),ORPQUE NECESITA TRATAMIENTO, DEFINIDACOMO RP TIPO 1 (ZONA 1, CUALQUIER ESTADI
RETCAMENVISIONTMES USED FOR: -GENERAL OPHTHALMOLOGICAL IMAGING, INCLUDING RETINAL, CORNEAL AND EXTERNAL IMAGING. -PHOTODOCUMENTATION OF PAEDIATRIC EYE DISEASES, INCLUDING RETINOPATHY OF PREMATURITY (PR). -SCREENING FOR RETINOPATHY OF PREPREMATURITY (PR)PREUMBRALTYPE2(ZONE1,STAGE1O2,NO ADDITIONAL PATHOLOGY, OR ZONE 2,STAGE3,ADDITIONAL PATHOLOGY),ORPQUE NEEDS TREATMENT, DEFINED AS PR TYPE 1 (ZONE 1, ANY STAGES)