Pure Global

Closed-ended adhesive infant/paediatric urine collection bag

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.

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TGA ARTG Official Data
Class Is
Class Is
Closed-ended adhesive infant/paediatric urine collection bag
Australia TGA ARTG Registered Device
Good Name: Advantage Health Care Pty Limited - Closed-ended adhesive infant/paediatric urine collection bag
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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

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
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316