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Open-ended wearable urine collection bag, sterile - ARTG 451926

Access comprehensive regulatory information for Open-ended 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 451926 and sponsored by Healthscope Operations PTY LTD, manufactured by Hangzhou Primecare Medical Co Ltd in China. The device registration started on June 12, 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 Is
ARTG 451926
Class Is
Open-ended wearable urine collection bag, sterile
ARTG ID: 451926
Good Name: Healthscope Operations PTY LTD - Open-ended wearable urine collection bag, sterile
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DJ Fang

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Intended Purpose

To connect to a urinary catheter and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage and can be worn on the body to facilitate patient mobility.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
451926
Start Date
June 12, 2024
Effective Date
June 12, 2024
Manufacturer
Country
China
Address
Room 408-409 Zancheng Center West, Shangcheng District, Hangzhou, 310008