Singapore HSA registration DE0503663
NIDEK Scanning Laser Ophthalmoscope Mirante
Singapore·CLASS B·NIDEK CO., LTD·Registered October 01, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0503663
- Registration Date
- October 01, 2019
- Change Notification Approval Date
- February 17, 2025
- Retention Due Date
- September 30, 2025
Product description
The Nidek Mirante with Normative Database is a non-contact ophthalmic imaging system. It is intended for use in capturing images of the fundus, including axial cross sectional imaging of ocular structures. It is used for in vivo imaging and measurement of the retina, retina 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.
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)
- Anterior Segment OCT Adapter Scanning Laser Ophthalmoscope Scanning Laser Ophthalmoscope Nidek Advanced Vision Information System Nidek Advanced Vision Information System
- Model Identifier(s)
- Anterior Segment OCT Adapter Mirante (SLO) Mirante (SLO/OCT) NAVIS-EX OCT Viewer for NAVIS-EX
About this record
Access comprehensive regulatory information for NIDEK Scanning Laser Ophthalmoscope Mirante in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503663 and owned by NIDEK CO., LTD. The device was registered on October 01, 2019.
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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