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

Access comprehensive regulatory information for Closed-ended non-wearable urine collection bag, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Coloplast Pty Ltd, manufactured by Coloplast AS in Denmark. The device registration started on June 09, 2023.

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
Class I
Closed-ended non-wearable urine collection bag, non-sterile
Australia TGA ARTG Registered Device
Good Name: Coloplast Pty Ltd - Closed-ended non-wearable urine collection bag, non-sterile
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Intended Purpose

The urine bag is intended to passively collect urine.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 09, 2023
Effective Date
June 09, 2023
Manufacturer
Country
Denmark
Address
Holtedam 1, Humlebaek, 3050