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Mocean 4000 Optical Coherence Tomographer - HSA Registration DE0509725

Access comprehensive regulatory information for Mocean 4000 Optical Coherence Tomographer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509725 and owned by Shenzhen CERTAINN Technology Co., Ltd.. The device was registered on September 03, 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
DE0509725
Mocean 4000 Optical Coherence Tomographer
HSA Registration Number: DE0509725
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Product Description

The Mocean 4000 OCT is an optical coherence tomographer indicated for in-vivo viewing, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures. In addition, Mocean 4000 OCT is indicated for OCT-angiography (OCT-A) that can detect the retinal blood vessel patterns.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0509725
Registration Date
September 03, 2024
Retention Due Date
September 02, 2025
Product Owner
Short Name
Shenzhen CERTAINN Technology Co., Ltd.
Address
L302, Bldg 2, Skyworth Innovation Valley, No. 8 Tangtou 1st Road, Tangtou Community, Bao'an District, Shenzhen, Guangdong, CHINA
Registrant
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Model Information
Model Name(s)
Optical Coherence Tomographer
Model Identifier(s)
Mocean 4000