Australia TGA ARTG record

Closed-ended adhesive infant/paediatric urine collection bag

Australia TGA ARTG Registered Device · Advantage Health Care Pty Limited · Aspen Surgical Products Inc · Class Is · Started October 13, 2022

Good Name: Advantage Health Care Pty Limited - Closed-ended adhesive infant/paediatric urine collection bag

Device classification

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

Registration information

Start Date: October 13, 2022
Effective Date: October 13, 2022

Sponsor

Name: Advantage Health Care Pty Limited

Manufacturer

Name: Aspen Surgical Products Inc
Country: United States of America
Address: 6945 Southbelt Drive SE, Caledonia, MI, 49316

Intended purpose

For the collection of urine for incontinent patients to be disposed of. For the collection of urine specimens from premature, newborn and paediatric patients

About this record

Access comprehensive regulatory information for Closed-ended adhesive infant/paediatric urine collection bag in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Advantage Health Care Pty Limited, manufactured by Aspen Surgical Products Inc in United States of America. The device registration started on October 13, 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.