Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Nipro Australia Pty Ltd · Nipro Corporation · Class IIb · Started May 16, 2024

Good Name: Nipro Australia 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: May 16, 2024
Effective Date: May 16, 2024

Sponsor

Name: Nipro Australia Pty Ltd

Manufacturer

Name: Nipro Corporation
Country: Japan
Address: 3-26 Senriokashinmachi, Settsu, Osaka, 566-8510

Intended purpose

Haemodialysis or Hemodiafiltration with Elisio-H (or -K) is indicated for patients having acute or chronic renal failure when dialysis is prescribed by the physician. Haemodialysis with Elisio-M and -L is indicated for patients having acute or chronic renal failure when dialysis is prescribed by the physician.

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 Nipro Australia Pty Ltd, manufactured by Nipro Corporation in Japan. The device registration started on May 16, 2024.

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.