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Dressing, occlusive, silicone

Access comprehensive regulatory information for Dressing, occlusive, silicone in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Cipla Australia Pty Ltd, manufactured by Cipla Limited in India. The device registration started on July 08, 2010.

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
Dressing, occlusive, silicone
Australia TGA ARTG Registered Device
Good Name: Cipla Australia Pty Ltd - Dressing, occlusive, silicone
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Intended Purpose

Repairaderm is used for the treatment and prevention of keloids and hypertrophic scars (such as those resulting from general surgical procedures,trauma wounds and burns),after the wound has healed and the skin surface is intact. Repairaderm is a topical silicone gel that is transparent,dries quickly and helps maintain the skinโ€™s moisture balance,while aiding the management of scarred skin surfaces resulting from surgery,burns,and other injuries. Repairaderm has been shown to flatten,soften and smooth scars,relieve the itching and discomfort of scars as well as reduce the discoloration associated with scars. Repairaderm gel is easily applied to all areas of the skin,including the face,joints and flexures,and dries rapidly to form an individual โ€œsheetโ€. Repairaderm was developed using the same basic long chain polymers as topical silicone gel sheeting,but is available in a tube. It contains polysiloxane.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 08, 2010
Effective Date
July 08, 2010
Manufacturer
Country
India
Address
Plot No S-103 L-139 & M-62, Verna Industrial Area, Verna Salcette, Goa, 403 722