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Huvitz Optical Coherence Tomography - HSA Registration DE0501943

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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CLASS B
DE0501943
Huvitz Optical Coherence Tomography
HSA Registration Number: DE0501943
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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.

Device 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 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)
Huvitz Optical Coherence Tomography HOCT-1 Huvitz Optical Coherence Tomography HOCT-1F
Model Identifier(s)
HOCT-1 HOCT-1F