Australia TGA ARTG record

Synthetic polymer semi-permeable film dressing, adhesive, sterile

Australia TGA ARTG Registered Device · BPositive Healthcare Pty Ltd · BPositive Pte Ltd · Class Is · Started August 30, 2023

Good Name: BPositive Healthcare Pty Ltd - Synthetic polymer semi-permeable film dressing, adhesive, sterile

Device classification

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

Registration information

Start Date: August 30, 2023
Effective Date: August 30, 2023

Sponsor

Name: BPositive Healthcare Pty Ltd

Manufacturer

Name: BPositive Pte Ltd
Country: Singapore
Address: Singapore Business Federation Centre 160 Robinson Road #14-04, Singapore, 068914

Intended purpose

The single use adhesive, polyurethane film dressing is a water & bacteria (non-antibacterial) proof film dressing, used to protect and reduce the risk of infection at the applied wound area for minor wounds, such as cuts, grazes and stitches.

About this record

Access comprehensive regulatory information for Synthetic polymer semi-permeable film dressing, adhesive, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by BPositive Healthcare Pty Ltd, manufactured by BPositive Pte Ltd in Singapore. The device registration started on August 30, 2023.

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.