Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: EyRIS SELENA+ [EyRIS Pte Ltd]
Description: SELENA+ is used in conjunction with a data management system, by healthcare professionals, as a decision-making aid in screening diabetic patients at risk of vision loss. SELENA+ provides automatic referable/non-referable recommendations to identify patients for signs of more than mild diabetic retinopathy (DR) using the International Clinical Diabetic Retinopathy Disease Severity Scale (ICDRSS) and diabetic macular edema (DME), referable/non-referable glaucoma suspect and referable/non-referable age-related macular degeneration (AMD).
Medical Specialty Area: Ophthalmology
Medical Device Class: Class B medical device
Device Registration No: DE0503735
Registration Date: 15/10/2019
Change Notification Approval Date: 15/06/2020
 
Product Owner
1. EyRIS Pte Ltd  [EyRIS Pte Ltd] 60 MACPHERSON ROAD, BLOCK 1 SIEMENS CENTRE, #05-08, SINGAPORE 348615
Registrant
1. EYRIS PTE. LTD.  60 MACPHERSON ROAD, THE SIEMENS CENTRE, #05-08, SINGAPORE 348615
Models
No. Model Name Identifier
1SELENA+SELENA+
2EySCANEySCAN
 
Note: All device listings on the Singapore Medical Device Register (SMDR) are active.