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Closed-ended non-wearable urine collection bag, sterile - ARTG 399130

Access comprehensive regulatory information for Closed-ended non-wearable urine collection bag, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 399130 and sponsored by Health One Pty Ltd, manufactured by Shanghai Kindly Enterprise Development Group Co Ltd in China. The device registration started on November 10, 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
ARTG 399130
Class Is
Closed-ended non-wearable urine collection bag, sterile
ARTG ID: 399130
Good Name: Health One Pty Ltd - Closed-ended non-wearable urine collection bag, sterile
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Intended Purpose

Sterile urine bags made by medical grade PVC are used to collect urine for patients bearing urine retention symptom, paraplegia patients and patients in bed for a long period.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399130
Start Date
November 10, 2022
Effective Date
November 10, 2022
Manufacturer
Country
China
Address
No 658 Gaochao Road, Shanghai, 201803