Direct ophthalmoscope, battery-powered - ARTG 466825
Access comprehensive regulatory information for Direct ophthalmoscope, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 466825 and sponsored by Paragon Care Group Australia Pty Ltd trading as Designs for Vision, manufactured by Keeler Ltd in United Kingdom. The device registration started on November 01, 2024.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The Keeler Ophthalmoscope is indicated for examining the posterior segment of the eye referred to as the fundus, in order to aid in the screening and diagnosis of retinal pathology including, but not limited to, diseases such as cataracts, papilledema, glaucomatous disc cupping, diabetic retinopathy, hypertensive retinopathy and retinal detachments. When set to a high power and magnification, it can also be used to examine the anterior segment of the eye, which includes the eyelids, cornea, sclera, conjunctiva, iris, aqueous, crystalline lens and anterior vitreous.