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Filtration system, semen - ARTG 462834

Access comprehensive regulatory information for Filtration system, semen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462834 and sponsored by Origio Australasia Pty Ltd, manufactured by ZyMot Fertility Inc in United States of America. The device registration started on September 25, 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 IIa
ARTG 462834
Class IIa
Filtration system, semen
ARTG ID: 462834
Good Name: Origio Australasia Pty Ltd - Filtration system, semen
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Intended Purpose

The ZyMลt Sperm Separation Devices are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF), and intrauterine insemination (IUI) procedures.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462834
Start Date
September 25, 2024
Effective Date
September 25, 2024
Manufacturer
Country
United States of America
Address
401 Professional Drive Suite 130, Gaithersburg, MD, 20879