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Haematological concentrate system kit, thrombin separation

Access comprehensive regulatory information for Haematological concentrate system kit, thrombin separation in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Avaderm Pty Ltd, manufactured by Str Biyo Teknolojileri Medikal Imalat Ithalat Ve Ihracat San Tic Ltd Sti in Turkey. The device registration started on December 22, 2021.

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 IIa
Class IIa
Haematological concentrate system kit, thrombin separation
Australia TGA ARTG Registered Device
Good Name: Avaderm Pty Ltd - Haematological concentrate system kit, thrombin separation
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Intended Purpose

The device is intended for the preparation of autologous platelet-rich-plasma (PRP) or platelet-rich-fibrin (PRF) from a patient's sample of blood. This platelet-rich plasma or platelet-rich-fibrin is then injected to repair a target tissue by causing rapid rejuvenation (tissue regeneration).

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 22, 2021
Effective Date
December 22, 2021
Sponsor
Manufacturer
Country
Turkey
Address
Mimarsinan Mah Kucuk Sanayi 27 Sokak No 2 Merkez, Corum