Singapore HSA registration DE0508407
NIDEK Optical Coherence Tomography RS-1
Singapore·CLASS B·NIDEK CO., LTD·Registered August 18, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0508407
- Registration Date
- August 18, 2023
- Change Notification Approval Date
- February 26, 2025
- Retention Due Date
- August 17, 2025
Product description
The Nidek Optical Coherence Tomography RS-1 with Normative Database is a non-contact ophthalmic imaging system for reviewing and axial cross sectional imaging of ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as an aid in the diagnosis and management of the retinal disease. In addition, the anterior segment adapter (special lens unit) attached over the objective lens of the main body enables non-invasive and non-contact observation of the shape of the anterior segment of the eye such as the cornea or anterior chamber angle. The functions for image review, image processing, and exporting are available. The filed images provide information for reference purposes.
Product Owner
- Name
- NIDEK CO., LTD
- Short Name
- NIDEK CO., LTD
- Address
- 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, SIGNATURE, THE, #06-14, SINGAPORE 486066 6 UBI ROAD 1, WINTECH CENTRE, #03-12, SINGAPORE 408726
Model information
- Model Name(s)
- Advanced Vision Information System Advanced Vision Information System Optical Coherence Tomography RS-1 Anterior Segment OCT Adapter
- Model Identifier(s)
- NAVIS-EX OCT Viewer for NAVIS-EX SA002-00S0 SAP02-1100
About this record
Access comprehensive regulatory information for NIDEK Optical Coherence Tomography RS-1 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508407 and owned by NIDEK CO., LTD. The device was registered on August 18, 2023.
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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