NIDEK Scanning Laser Ophthalmoscope Mirante - HSA Registration DE0503663
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.
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.