Australia TGA ARTG record

Biological sterilization indicator reader

Australia TGA ARTG Registered Device · Medical & Optical Instruments Australia Pty Ltd · SP Medikal San Ltd · Class I · Started June 27, 2018

Good Name: Medical & Optical Instruments Australia Pty Ltd- Biological sterilization indicator reader

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: June 27, 2018
Effective Date: June 27, 2018

Sponsor

Name: Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Name: SP Medikal San Ltd
Country: Turkey
Address: Topcular Mah Incirlik Sokak Ertas Is Merkezi No 5/56 Kat 2 Rami Eyup, Istanbul

Intended purpose

A mains electricity (AC-powered) device designed to accept a biological sterilization indicator and to rapidly indicate whether adequate sterilization conditions have been achieved by testing the resistance of the biological indicator previously exposed to a sterilization process.

About this record

Access comprehensive regulatory information for Biological sterilization indicator reader in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Medical & Optical Instruments Australia Pty Ltd, manufactured by SP Medikal San Ltd in Turkey. The device registration started on June 27, 2018.

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.