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ORIGIO Handling 8310 (without Phenol red) - In vitro fertilization culture medium

Access comprehensive regulatory information for ORIGIO Handling 8310 (without Phenol red) - 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 Origio A/S in Denmark. The device registration started on May 04, 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.

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Class III
Class III
ORIGIO Handling 8310 (without Phenol red) - In vitro fertilization culture medium
Australia TGA ARTG Registered Device
Good Name: Origio Australasia Pty Ltd - ORIGIO Handling 8310 (without Phenol red) - In vitro fertilization culture medium
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Intended Purpose

ORIGIO Handling is intended for ART (assisted reproduction techniques) procedures involving handling and micromanipulation of gametes and embryos outside a CO2 incubator. Indications include oocyte retrieval (incl. follicle flushing), gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including ICSI, assisted hatching, polar body and trophectoderm biopsy.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 04, 2021
Effective Date
May 04, 2021
Manufacturer
Country
Denmark
Address
Knardrupvej 2, Malov, DK-2760