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Huvitz Auto-Ref / Keratometer HRK-9000A - HSA Registration DE0018249

Access comprehensive regulatory information for Huvitz Auto-Ref / Keratometer HRK-9000A in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018249 and owned by Huvitz Co., Ltd.. The device was registered on June 14, 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
DE0018249
Huvitz Auto-Ref / Keratometer HRK-9000A
HSA Registration Number: DE0018249
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Product Description

The Auto Ref/Keratometer HRK-9000A is intended to be used to measure the refractive power of the eye.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0018249
Registration Date
June 14, 2016
Change Notification Approval Date
October 27, 2017
Retention Due Date
June 13, 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)
Auto Ref / Keratometer HRK-9000A RM Calibration set
Model Identifier(s)
HRK-9000A RMCal0001