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

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Hollow-fibre haemodialysis dialyser, high flux, single-use
Australia TGA ARTG Registered Device
Good Name: Nipro Australia Pty Ltd - Hollow-fibre haemodialysis dialyser, high flux, single-use
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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.

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
Manufacturer
Country
Japan
Address
3-26 Senriokashinmachi, Settsu, Osaka, 566-8510