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Singapore HSA registration DE0011325

HUVITZ Auto Ref/Keratometer

Singapore flagSingapore·CLASS B·Huvitz Co., Ltd.·Registered October 10, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0011325
Registration Date
October 10, 2012
Change Notification Approval Date
July 12, 2024
Retention Due Date
October 09, 2025
Product description
Huvitz Auto Ref/Keratometer is the equipment to provide the information of Spherical, Cylindrical and Axis while measuring the refraction of examinee’s eyes. Auto Ref/Keratometer is the equipment that can measure the corneal curvature of examinee. In addition, it can measure PD (=distance in between pupils) and pupil size. Especially, as its peripheral (=corneal peripheral curvature) measurement is possible as measuring the corneal curvature of examinee, it is possible to know the information on the corneal peripheral curvature as well as the corneal core curvature, which enables the exact prescription for the examinee.
Product Owner
Name
Huvitz Co., Ltd.
Short Name
Huvitz Co., Ltd.
Address
38, Burim-ro, 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, KOREA, REPUBLIC OF
Registrant
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
Model Name(s)
Auto Ref/Keratometer HRK-8000A Auto Ref/Keratometer HRK-8100A RM Calibration set
Model Identifier(s)
HRK8000A HRK8100A RMCal0001
About this record

Access comprehensive regulatory information for HUVITZ Auto Ref/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 DE0011325 and owned by Huvitz Co., Ltd.. The device was registered on October 10, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B