Crystalvue Nikon RetinaStation Non-mydriatic Fundus Camera - HSA Registration DE0504371
Access comprehensive regulatory information for Crystalvue Nikon RetinaStation Non-mydriatic Fundus Camera in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504371 and owned by Crystalvue Medical Corporation. The device was registered on April 15, 2020.
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.
RetinaStation provides non-mydriatic color retina and external images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. RetinaStation, which uses NIR LED as illumination when aligning to the retina of a patient’s eyes, only provides images and does not provide any diagnostic or pathological analysis or conclusions in any way. Furthermore, RetinaStation is not intended to be used as the sole diagnostic aid in disease identification, classification or management. RetinaStation is designed to provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases.