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Sterilization process indicator, biological - ARTG 421355

Access comprehensive regulatory information for Sterilization process indicator, biological in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 421355 and sponsored by Proline Medical Pty Ltd, manufactured by Terragene SA in Argentina. The device registration started on September 06, 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 I
ARTG 421355
Class I
Sterilization process indicator, biological
ARTG ID: 421355
Good Name: Proline Medical Pty Ltd - Sterilization process indicator, biological
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Intended Purpose

For use in the routine monitoring of steam and low temperature hydrogen peroxide sterilisation processes.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421355
Start Date
September 06, 2023
Effective Date
September 06, 2023
Manufacturer
Country
Argentina
Address
Ruta Nacional 9 Km 280, Alvear, Santa Fe, CP 2130