Pure Global

Lens, spectacle

Access comprehensive regulatory information for Lens, spectacle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Rodenstock Australia Pty Ltd, manufactured by Rodenstock GmbH in Germany. The device registration started on March 27, 2023.

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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TGA ARTG Official Data
Class I
Class I
Lens, spectacle
Australia TGA ARTG Registered Device
Good Name: Rodenstock Australia Pty Ltd - Lens, spectacle
Pure Global
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Intended Purpose

A single vision spectacle lens in meniscus shape (convex concave lenses) for the correction of customised myopia and to reduce the risk of progressive myopia. The modified optical design of the lens, with a horizontal increase in refractive power on both sides and an optical centre for central imaging, is intended on the one hand to ensure the appropriate corrective effect and on the other hand to create an image in front of the retina via the peripheral increase in refractive power in the lens.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 27, 2023
Effective Date
March 27, 2023
Manufacturer
Country
Germany
Address
Elsenheimerstrasse 33, Munchen, 80687