Singapore HSA registration DE0503735
EyRIS SELENA+
Singapore·CLASS B·EyRIS Pte Ltd·Registered October 15, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0503735
- Registration Date
- October 15, 2019
- Change Notification Approval Date
- August 15, 2023
- Retention Due Date
- October 14, 2025
Product 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.
Product Owner
- Name
- EyRIS Pte Ltd
- Short Name
- EyRIS Pte Ltd
- Address
- 60 MACPHERSON ROAD, BLOCK 1 SIEMENS CENTRE, #05-08, SINGAPORE 348615
Registrant
- Name
- EYRIS PTE. LTD.
- Address
- 60 MACPHERSON ROAD, BLOCK 1 SIEMENS CENTRE, #05-08, SINGAPORE 348615
Model information
- Model Name(s)
- EySCAN SELENA+
- Model Identifier(s)
- EySCAN SELENA+
About this record
Access comprehensive regulatory information for EyRIS SELENA+ in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503735 and owned by EyRIS Pte Ltd. The device was registered on October 15, 2019.
This page provides complete registration details including product owner information, registrant details, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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