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BlastGen / EmbryoGen - In vitro fertilization culture medium kit

Access comprehensive regulatory information for BlastGen / EmbryoGen - In vitro fertilization culture medium kit 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 Origio A/S in Denmark. The device registration started on November 30, 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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TGA ARTG Official Data
Class III
Class III
BlastGen / EmbryoGen - In vitro fertilization culture medium kit
Australia TGA ARTG Registered Device
Good Name: Origio Australasia Pty Ltd - BlastGen / EmbryoGen - In vitro fertilization culture medium kit
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Intended Purpose

BlastGen™ is for the culture of 4-8 cell stage human embryos to the blastocyst stage. BlastGen™ may also be used for embryo transfer. EmbryoGen® is for the culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer on Day 2 or Day 3.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
November 30, 2023
Effective Date
November 30, 2023
Manufacturer
Country
Denmark
Address
Knardrupvej 2, Malov, DK-2760