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Platelet concentration kit, wound-healing

Australia TGA ARTG Registered Device · Johel Holdings Pty Ltd T/A Alocuro · GoodmorningBio Co Ltd · Class IIa · Started November 12, 2014

Good Name: Johel Holdings Pty Ltd T/A Alocuro - Platelet concentration kit, wound-healing

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
November 12, 2014
Effective Date
November 12, 2014
Sponsor
Manufacturer
Country
South Korea
Address
30 Beon-Gil 492 Dokbae-Ro Nam-Gu, Incheon, 402-010
Intended purpose

PRO-PRP platelet separation device is a point of care device used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of venous blood. Once the venous blood has been introduced into the device under aseptic technique, the device is placed in a centrifuge to optimise platelet concentration within the plasma, from the whole blood sample. The PRP is then withdrawn under aseptic technique and injected into or applied to the target area by a medical practitioner to assist regeneration of soft tissues and wound-healing.

About this record

Access comprehensive regulatory information for Platelet concentration kit, wound-healing in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Johel Holdings Pty Ltd T/A Alocuro, manufactured by GoodmorningBio Co Ltd in South Korea. The device registration started on November 12, 2014.

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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