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Singapore HSA registration DE0509725

Mocean 4000 Optical Coherence Tomographer

Singapore flagSingapore·CLASS B·Shenzhen CERTAINN Technology Co., Ltd.·Registered September 03, 2024
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 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.
Product Owner
Name
Shenzhen CERTAINN Technology Co., Ltd.
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
Name
VITOP PTE.LTD.
Address
15 LORONG 8 TOA PAYOH, BRADDELL TECH, #04-03, SINGAPORE 319262
Importer
Name
VITOP PTE.LTD.
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
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B