Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: EyRIS SELENA+ [EyRIS Pte Ltd]
Description: EyRIS SELENA+ is an automated system through the analysis of colour fundus retinal images, intended for use by healthcare professionals, to detect diabetic patients at risk of vision loss. EyRIS SELENA+ can automatically detect 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), in the eyes of adults diagnosed with diabetes. The output is intended to help healthcare providers decide which diabetic patients need referral to an eye care provider for further evaluation and management.
Medical Specialty Area: Ophthalmology
Medical Device Class: Class B medical device
Device Registration No: DE0503735
Registration Date: 15/10/2019
Change Notification Approval Date: 15/08/2023
 
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, BLOCK 1 SIEMENS CENTRE, #05-08, SINGAPORE 348615
Models
No. Model Name Identifier UDI-DI DM-DI Place of Manufacture
1SELENA+SELENA+SINGAPORE
2EySCANEySCANSINGAPORE
 
Note: All device listings on the Singapore Medical Device Register (SMDR) are active. Class A medical devices are not registered in the SMDR. To retrieve Class A medical devices, please visit Class A Medical Device Database.