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Huvitz Digital Refractor HDR-9000 - HSA Registration DE0018679

Access comprehensive regulatory information for Huvitz Digital Refractor HDR-9000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018679 and owned by Huvitz Co., Ltd.. The device was registered on October 19, 2016.

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
DE0018679
Huvitz Digital Refractor HDR-9000
HSA Registration Number: DE0018679
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Product Description

The HUVITZ Digital Refractor HDR-9000 system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities. Also the Digital Refractor is used for detecting and measuring any anomalies in binocular vision such as muscle balance, binocular balance, aniseikonia, fusion, and stereopsis.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0018679
Registration Date
October 19, 2016
Change Notification Approval Date
October 27, 2017
Retention Due Date
October 18, 2025
Product Owner
Short Name
Huvitz Co., Ltd.
Address
38, Burim-ro, 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, KOREA, REPUBLIC OF
Registrant
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model Information
Model Name(s)
HDR-9000 CONVERTER BOX DGITAL REFRATOR HDR-9000 PC Package Auto Lensmeter Package Auto Ref/Keratormeter Package DGITAL REFRATOR HDR-9000(JB)
Model Identifier(s)
D6_OP-TOTAL-ASSY HDR-9000 Interface Cable (9 pin D-SUB) Interface Cable (9-pin D-SUB) Interface Cable(9-pin D-SUB) JUNCTION-BOX-ASSY