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SAGE 1-Step GM-CSF - In vitro fertilization culture medium - ARTG 455145

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 registered under ARTG number 455145 and 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.

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Class III
ARTG 455145
Class III
SAGE 1-Step GM-CSF - In vitro fertilization culture medium
ARTG ID: 455145
Good Name: Origio Australasia Pty Ltd - SAGE 1-Step GM-CSF - In vitro fertilization culture medium
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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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
455145
Start Date
July 12, 2024
Effective Date
July 12, 2024
Manufacturer
Country
United States of America
Address
95 Corporate Drive, Trumbull, Connecticut, 06611