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Open-ended non-wearable urine collection bag, sterile - ARTG 481073

Access comprehensive regulatory information for Open-ended non-wearable urine collection bag, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 481073 and sponsored by Sentry Medical Pty Ltd, manufactured by Hangzhou Primecare Medical Co Ltd in China. The device registration started on February 27, 2025.

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 I
ARTG 481073
Class I
Open-ended non-wearable urine collection bag, sterile
ARTG ID: 481073
Good Name: Sentry Medical Pty Ltd - Open-ended non-wearable urine collection bag, sterile
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Intended Purpose

A non-sterile flexible plastic pouch intended to connect to a urinary catheter or a urinary condom catheter to collect urine from a patient; it is designed with an opening for urine drainage.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481073
Start Date
February 27, 2025
Effective Date
February 27, 2025
Manufacturer
Country
China
Address
Room 408-409 Zancheng Center West, Shangcheng District, Hangzhou, 310008