Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medical Devices and Testing Pty Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
ARTG entry for
Medical Device Included Class IIa
Medical Devices and Testing Pty Ltd
PO Box 114,Pyrmont, NSW, 2009
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.
Alpinion Medical Systems Co Ltd
1FL and 6FL Verdi Tower 72 Digital-ro (St)
Guro-gu, Seoul, 08393
Korea - Republic of
1. Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
Single Device Product
40771 Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
specifically designed to be positioned within the vagina either manually or under endoscopic guidance. It
steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:51:27 AEDT
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