Singapore HSA registration DE0507303
VUNO VUNO Med-Fundus AI
Singapore·CLASS B·VUNO Inc.·Registered September 23, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0507303
- Registration Date
- September 23, 2022
- Change Notification Approval Date
- October 25, 2024
- Retention Due Date
- September 22, 2025
Product description
The software automatically analyzes the image of fundus and provides findings with a region of interest(ROI) . Determining 12 findings that can be a disease as below; a. hemorrhage b. hard exudate c. cotton wool patch d. drusen e. membrane f. macular hole g. myelinated nerve fiber h. chorioretinal atrophy i. vascular abnormality j. retinal nerve fiber layer defect k. glaucomatous disc change l. non-glaucomatous disc change - Intended user: Trained Ophthalmologist and healthcare professionals
Product Owner
- Name
- VUNO Inc.
- Short Name
- VUNO Inc.
- Address
- 9F, 479, Gangnam-daero, Seocho-gu, 06541, Seoul, KOREA, REPUBLIC OF
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model information
- Model Name(s)
- VUNO Med-Fundus AI
- Model Identifier(s)
- VN-M-03
About this record
Access comprehensive regulatory information for VUNO VUNO Med-Fundus AI in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507303 and owned by VUNO Inc.. The device was registered on September 23, 2022.
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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