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Organ preservation solution - ARTG 475849

Access comprehensive regulatory information for Organ preservation solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 475849 and sponsored by Stark Medical, manufactured by SALF Spa Laboratorio Farmacologico in Italy. The device registration started on January 15, 2025.

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 475849
Class IIa
Organ preservation solution
ARTG ID: 475849
Good Name: Stark Medical - Organ preservation solution
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Intended Purpose

Intended for flushing and hypothermic preservation of thoracic organs (heart and lung) and abdominal organs (kidney, liver, pancreas) during transplantation. The solution is to be used to flush the isolated organ immediately before, after removal from a dead donor or immediately after removal from a living donor. This is sterile device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475849
Start Date
January 15, 2025
Effective Date
January 15, 2025
Sponsor
Manufacturer
Country
Italy
Address
Via Marconi 2-24069, Cenate Sotto, Bergamo