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Huvitz Digital Refractor HDR-7000 - HSA Registration DE0010835

Access comprehensive regulatory information for Huvitz Digital Refractor HDR-7000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010835 and owned by Huvitz Co., Ltd.. The device was registered on September 12, 2012.

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
DE0010835
Huvitz Digital Refractor HDR-7000
HSA Registration Number: DE0010835
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Product Description

HUVITZ Digital Refractor HDR-7000 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
HSA Product Code
HSAMDB00108
HS Code
90185000
Registration Information
Registration Number
DE0010835
Registration Date
September 12, 2012
Change Notification Approval Date
October 27, 2017
Retention Due Date
September 11, 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)
DGITAL REFRATOR HDR-7000 HDR-7000 CONVERTER BOX DGITAL REFRATOR HDR-7000(JB) Auto Ref/Keratormeter Package Auto Lensmeter Package PC Package
Model Identifier(s)
Ref no: HDR0001 Ref no: HDR0002 Ref no: HDR0003 Ref no: HDR0004 Ref no: HDR0005 Ref no: HDR0006