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Huvitz Optical Biometer - HSA Registration DE0510045

Access comprehensive regulatory information for Huvitz Optical Biometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510045 and owned by Huvitz Co., Ltd.. The device was registered on November 15, 2024.

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
DE0510045
Huvitz Optical Biometer
HSA Registration Number: DE0510045
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Product Description

The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature radii *Corneal cylinder axis *Anterior chamber depth *Central corneal thickness *Crystalline lens thickness *White-to-white *Pupil diameter. The Optical Biometer HBM-1 also measures corneal topography.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510045
Registration Date
November 15, 2024
Retention Due Date
November 14, 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)
Optical Biometer HBM-1
Model Identifier(s)
HBM-1