Australia TGA ARTG recordRestore Tears - Lubricant, eye
Australia TGA ARTG Registered Device · Petrus Pharmaceuticals Pty Ltd · Farmigea SPA · Class III · Started April 23, 2024
Good Name: Petrus Pharmaceuticals Pty Ltd - Restore Tears - Lubricant, eye
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 23, 2024
- Effective Date
- April 23, 2024
- Name
- Farmigea SPA
- Country
- Italy
- Address
- via GB Oliva 6/8, Pisa PI, 56121
The device is an ophthalmic solution of high-molecular weight Sodium Hyaluronate, obtained by biotechnological synthesis. Sodium Hyaluronate is a substance that originates mucomimetic solutions, with optimal lubricant properties due to the viscosity of the solutions that result in a moisturising effect and stabilization of the tear film. The lubricant, moisturising and protective qualities of sodium hyaluronate relieve irritation, dryness, burning and foreign body sensation due to environmental elements (wind, sun, smoke, dry air), visual stress (excessive light and prolonged use of computers) or mechanical factors (contact lens use), providing a long lasting relief. The product is preservative free suitable for use with contact lenses.
Access comprehensive regulatory information for Restore Tears - Lubricant, eye in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Petrus Pharmaceuticals Pty Ltd, manufactured by Farmigea SPA in Italy. The device registration started on April 23, 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.