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Open-ended non-wearable urine collection bag, sterile - ARTG 391890

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 Is is registered under ARTG number 391890 and sponsored by BKLT Advisory Pty Ltd, manufactured by Pacific Hospital Supply Co Ltd in Taiwan. The device registration started on July 06, 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 391890
Class Is
Open-ended non-wearable urine collection bag, sterile
ARTG ID: 391890
Good Name: BKLT Advisory Pty Ltd - Open-ended non-wearable urine collection bag, sterile
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Pricing
Intended Purpose

A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
391890
Start Date
July 06, 2022
Effective Date
July 06, 2022
Manufacturer
Country
Taiwan
Address
4F No 160 Daye Road, Beitou Distict, Taipei, 112