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UNICOS Auto Refracto-Keratometer - HSA Registration DE0507344

Access comprehensive regulatory information for UNICOS Auto Refracto-Keratometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507344 and owned by UNICOS Co., Ltd.. The device was registered on October 04, 2022.

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
DE0507344
UNICOS Auto Refracto-Keratometer
HSA Registration Number: DE0507344
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Product Description

The URK-700A/URK-800A/URK-900F Auto Refracto-Keratometer is used to determine the initial objective refractive values for a patient’s eye in the workflow of refraction to determine the optical prescriptions for myopia, hyperopia and astigmatism.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0507344
Registration Date
October 04, 2022
Retention Due Date
October 03, 2025
Product Owner
Short Name
UNICOS Co., Ltd.
Address
282-30, Munji-ro,, Yuseong-gu, Daejeon, KOREA, REPUBLIC OF
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)
Auto Refracto-Keratometer Auto Refracto-Keratometer Auto Refracto-Keratometer
Model Identifier(s)
URK-700A URK-800A URK-900F