Australia TGA ARTG record

Sterilization packaging, single-use

Australia TGA ARTG Registered Device · Medical & Optical Instruments Australia Pty Ltd · SP Medikal San Ltd · Class I · Started October 15, 2021

Good Name: Medical & Optical Instruments Australia Pty Ltd- Sterilization packaging, single-use

Device classification

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

Registration information

Start Date: October 15, 2021
Effective Date: October 15, 2021

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 device intended to be used to enclose medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also maintain sterility of the device until the packaging is opened.

About this record

Access comprehensive regulatory information for Sterilization packaging, single-use 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 October 15, 2021.

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.