Summary for ARTG Entry:
MD Solutions Australasia Pty Ltd - Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
ARTG entry for
Medical Device Included Class IIb
MD Solutions Australasia Pty Ltd
Unit 1/16-18 Tennyson Street,WILLIAMSTOWN NORTH, VIC, 3016
ARTG Start Date
Medical Device Class IIb
- 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.
Zephyr Surgical Implants
Rue du Conseil-General 14
Geneve, , CH-1205
1. Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
Medical device system
36250 Prosthesis, internal, penile, inflatable
The penile implant is a prosthesis that produces erections. This hydraulic implant comprises two inflatable
cylinders (hollow implants), which are implanted in the penis. They are connected to a reservoir, implanted
in the pelvis, and a manual pump implanted in the scrotum. This implant is mostly manufactured from
silicone. The hollow implants are filled under pressure to trigger penile rigidity.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:09:33 AEDT
This is not an ARTG Certificate document.
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