Australia TGA ARTG record

Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial

Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd · Integra Lifesciences Corporation · Class III · Started June 18, 2024

Good Name: Johnson & Johnson Medical Pty Ltd - Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 18, 2024
Effective Date: June 18, 2024

Sponsor

Name: Johnson & Johnson Medical Pty Ltd

Manufacturer

Name: Integra Lifesciences Corporation
Country: United States of America
Address: 1100 Campus Road, Princeton, New Jersey, 08540

Intended purpose

For use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter-related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.

About this record

Access comprehensive regulatory information for Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Johnson & Johnson Medical Pty Ltd, manufactured by Integra Lifesciences Corporation in United States of America. The device registration started on June 18, 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.