Pure Global

Platelet concentration kit, wound-healing - ARTG 230415

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 registered under ARTG number 230415 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 230415
Class IIa
Platelet concentration kit, wound-healing
ARTG ID: 230415
Good Name: Johel Holdings Pty Ltd T/A Alocuro - Platelet concentration kit, wound-healing
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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 The PRP is then withdrawn under aseptic technique and injected into or applied to the target area by a medical practitioner to assist regeneration of soft tissues and wound-healing.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
230415
Start Date
November 12, 2014
Effective Date
November 12, 2014
Manufacturer
Country
South Korea
Address
30 Beon-Gil 492 Dokbae-Ro Nam-Gu, Incheon, 402-010