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Shanghai MediWorks V100 Vision Screener - HSA Registration DE0510082

Access comprehensive regulatory information for Shanghai MediWorks V100 Vision Screener in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510082 and owned by Shanghai MediWorks Precision Instruments Co., Ltd.. The device was registered on November 27, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, 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
DE0510082
Shanghai MediWorks V100 Vision Screener
HSA Registration Number: DE0510082
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Product Description

The vision screener is designed to capture and record red reflex images, which contain information about eye conditions to assist in eye examinations. Accurate diagnosis of refractive status or prescription of glasses requires professional optometric testing at a medical institution.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510082
Registration Date
November 27, 2024
Retention Due Date
November 26, 2025
Product Owner
Short Name
Shanghai MediWorks Precision Instruments Co., Ltd.
Address
No.7, MingPu Phase โ…ก, No.3279 SanLu Road, MinHang District, 201100, Shanghai, CHINA
Registrant
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Importer
Address
65 UBI ROAD 1, OXLEY BIZHUB, #03-74, SINGAPORE 408729
Model Information
Model Name(s)
Vision Screener
Model Identifier(s)
V100