Singapore HSA registration DE0501943
Huvitz Optical Coherence Tomography
Singapore·CLASS B·Huvitz Co., Ltd.·Registered July 24, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0501943
- Registration Date
- July 24, 2018
- Change Notification Approval Date
- April 20, 2022
- Retention Due Date
- July 23, 2025
Product description
The HOCT-1, HOCT-1F is intended for use to aid in the diagnosis and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy and aged related macular degeneration which are occurred at a macular, an optic disk, an inner structure of retina, and a cornea.
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)
- Huvitz Optical Coherence Tomography HOCT-1 Huvitz Optical Coherence Tomography HOCT-1F
- Model Identifier(s)
- HOCT-1 HOCT-1F
About this record
Access comprehensive regulatory information for Huvitz Optical Coherence Tomography in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501943 and owned by Huvitz Co., Ltd.. The device was registered on July 24, 2018.
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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