Summary for ARTG Entry:
Origio Australasia Pty Ltd - Assisted reproduction microtool
ARTG entry for
Medical Device Included Class IIa
Origio Australasia Pty Ltd
31 / 7 Sefton Road,THORNLEIGH, NSW, 2120
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
2400 Hunters Way
Charlottesville, Virginia, 22911
United States Of America
1. Assisted reproduction microtool
Single Device Product
46553 Assisted reproduction microtool
For manipulation and transfer of human oocytes and embryos during IVF and ICSI (Intracytoplasmic
Sperm Injection) procedures. To be used in various non-invasive non-patient contact IVF procedures to
manipulate human oocytes and gametes in the laboratory, e.g. assisted hatching, blastomere biopsy,
denuding oocytes, holding and immobilization of oocytes or blastocysts, ICSI, polar body biopsy and PZD
(Partial Zona Dissection).
No Specific Conditions included on Record
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Produced at 09.11.2017 at 10:47:08 AEDT
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