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Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial - ARTG 452665

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 registered under ARTG number 452665 and 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.

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TGA ARTG Official Data
Class III
ARTG 452665
Class III
Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial
ARTG ID: 452665
Good Name: Johnson & Johnson Medical Pty Ltd - Biopatch Protective Disk with CHG - Exudate-absorbent dressing, non-hydrophilic-gel-forming, antimicrobial
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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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
452665
Start Date
June 18, 2024
Effective Date
June 18, 2024
Manufacturer
Country
United States of America
Address
1100 Campus Road, Princeton, New Jersey, 08540