Australia TGA ARTG recordWound hydrogel dressing, sterile
Australia TGA ARTG Registered Device · Pharmacare Laboratories Pty Ltd · Oystershell NV · Class IIb · Started February 16, 2022
Good Name: Pharmacare Laboratories Pty Ltd - Wound hydrogel dressing, sterile
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- February 16, 2022
- Effective Date
- February 16, 2022
- Name
- Oystershell NV
- Country
- Belgium
- Address
- Nijverheidsweg 10, Merelbeke, 9820
A non-sterile wound care hydrogel that forms a wound cover/barrier promoting wound healing by maintaining a moist wound environment that is intended to protect the wound from external contaminants and infection, provide a soothing effect/reducing the sensation of pain and discomfort, and promote optimum skin wound healing/recovery and reduced appearance of scarring. For the management and treatment of minor, acute and superficial wounds such as: abrasions (grazed skin), chafed or cracked skin, cuts and lacerations, and minor burns and sunburn.
Access comprehensive regulatory information for Wound hydrogel dressing, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Pharmacare Laboratories Pty Ltd, manufactured by Oystershell NV in Belgium. The device registration started on February 16, 2022.
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.