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Haematological concentrate system kit, platelet concentration

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 IIa is sponsored by Surgical Specialties Pty Ltd, manufactured by Ranfac Corporation in United States of America. The device registration started on August 25, 2023.

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
Class IIa
Haematological concentrate system kit, platelet concentration
Australia TGA ARTG Registered Device
Good Name: Surgical Specialties Pty Ltd - Haematological concentrate system kit, platelet concentration
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Intended Purpose

The Cervos Platelet Separator system is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood for mixing with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 25, 2023
Effective Date
August 25, 2023
Manufacturer
Country
United States of America
Address
30 Doherty Avenue, AVON, MA, 02322