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Catheter balloon inflation system, single-use

Access comprehensive regulatory information for Catheter balloon inflation system, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Medline International Two Australia Pty Ltd, manufactured by Shanghai Kindly Medical Instruments Co Ltd in China. The device registration started on June 07, 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 Is
Class Is
Catheter balloon inflation system, single-use
Australia TGA ARTG Registered Device
Good Name: Medline International Two Australia Pty Ltd - Catheter balloon inflation system, single-use
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Intended Purpose

Inflation device is an assembly of devices used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. This is typically fitted with a threaded plunger assembly with lock/release bar, a flexible high pressure extension tube, and a three-way medium pressure stopcock. This is a single use device.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 07, 2023
Effective Date
June 07, 2023
Manufacturer
Country
China
Address
No 925 Jinyuan yi Road, Shanghai, 201803