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VUNO VUNO Med-Fundus AI - HSA Registration DE0507303

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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CLASS B
DE0507303
VUNO VUNO Med-Fundus AI
HSA Registration Number: DE0507303
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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

Device 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 Owner
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