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Ophthalmologic/otologic diagnostic set

Access comprehensive regulatory information for Ophthalmologic/otologic diagnostic set in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Epique Biomedical Solutions Pty Ltd, manufactured by Kirchner & Wilhelm in Germany. The device registration started on May 08, 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.

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Class I
Class I
Ophthalmologic/otologic diagnostic set
Australia TGA ARTG Registered Device
Good Name: Epique Biomedical Solutions Pty Ltd - Ophthalmologic/otologic diagnostic set
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Intended Purpose

A collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
May 08, 2024
Effective Date
May 08, 2024
Manufacturer
Country
Germany
Address
Eberhardstrasse 56, ASPERG 1, 7144