Australia TGA ARTG record

Hollow-fibre haemodialysis dialyser, high flux, single-use

Australia TGA ARTG Registered Device · Vitramed Pty Ltd · Suzhou Jun Kang Medical Technology Co Ltd · Class IIb · Started March 03, 2023

Good Name: Vitramed Pty Ltd - Hollow-fibre haemodialysis dialyser, high flux, single-use

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 03, 2023
Effective Date: March 03, 2023

Sponsor

Name: Vitramed Pty Ltd

Manufacturer

Name: Suzhou Jun Kang Medical Technology Co Ltd
Country: China
Address: No 28 Wutaishan Rd SND (SSTT) Suzhou, Jiangsu, 215163

Intended purpose

A filter that is a single use device used for hemodialysis for patients with chronic or acute renal failure.

About this record

Access comprehensive regulatory information for Hollow-fibre haemodialysis dialyser, high flux, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Vitramed Pty Ltd, manufactured by Suzhou Jun Kang Medical Technology Co Ltd in China. The device registration started on March 03, 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.