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Wound therapy autologous blood clot preparation kit - ARTG 464666

Access comprehensive regulatory information for Wound therapy autologous blood clot preparation kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 464666 and sponsored by Smartfem Pty Ltd, manufactured by Smartfem Pty Ltd in Australia. The device registration started on October 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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Class IIa
ARTG 464666
Class IIa
Wound therapy autologous blood clot preparation kit
ARTG ID: 464666
Good Name: Smartfem Pty Ltd - Wound therapy autologous blood clot preparation kit
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Intended Purpose

System for producing autologous blood clot graft from patientโ€™s own whole blood. The resultant graft is implanted at the time of native tissue repair surgery with the aim of promoting tissue augmentation. One system allows for the creation of two autologous grafts from the one patient for immediate use in one surgical procedure.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
464666
Start Date
October 16, 2024
Effective Date
October 16, 2024
Sponsor
Manufacturer
Country
Australia
Address
46 Marlstone Avenue, Ashford, SA, 5035