Australia TGA ARTG record

SAGE 1-Step GM-CSF - In vitro fertilization culture medium

Australia TGA ARTG Registered Device · Origio Australasia Pty Ltd · CooperSurgical Inc · Class III · Started July 12, 2024

Good Name: Origio Australasia Pty Ltd - SAGE 1-Step GM-CSF - In vitro fertilization culture medium

Device classification

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

Registration information

Start Date: July 12, 2024
Effective Date: July 12, 2024

Sponsor

Name: Origio Australasia Pty Ltd

Manufacturer

Name: CooperSurgical Inc
Country: United States of America
Address: 95 Corporate Drive, Trumbull, Connecticut, 06611

Intended purpose

For culture through to the blastocyst stage. Should also be used for embryo transfer. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

About this record

Access comprehensive regulatory information for SAGE 1-Step GM-CSF - In vitro fertilization culture medium in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Origio Australasia Pty Ltd, manufactured by CooperSurgical Inc in United States of America. The device registration started on July 12, 2024.

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.