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Haematological concentrate system kit, platelet concentration - ARTG 471566

Access comprehensive regulatory information for Haematological concentrate system kit, platelet concentration in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471566 and sponsored by Integrant Pty Ltd, manufactured by T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San Ve Tic LTD STI in Turkey. The device registration started on December 03, 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
ARTG 471566
Class IIb
Haematological concentrate system kit, platelet concentration
ARTG ID: 471566
Good Name: Integrant Pty Ltd - Haematological concentrate system kit, platelet concentration
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Intended Purpose

The device is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of the patient's blood at the point of care.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
471566
Start Date
December 03, 2024
Effective Date
December 03, 2024
Manufacturer
Country
Turkey
Address
Dumlupฤฑnar mah Kuleli Cad No 3, Nilufer, Bursa