Singapore HSA registration DE0510045
Huvitz Optical Biometer
Singapore·CLASS B·Huvitz Co., Ltd.·Registered November 15, 2024Device 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 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.
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
- 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
About this record
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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