Pure Global

Restore Tears - Lubricant, eye

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
Class III
Restore Tears - Lubricant, eye
Australia TGA ARTG Registered Device
Good Name: Petrus Pharmaceuticals Pty Ltd - Restore Tears - Lubricant, eye
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 23, 2024
Effective Date
April 23, 2024
Manufacturer
Country
Italy
Address
via GB Oliva 6/8, Pisa PI, 56121