Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medical Devices and Testing Pty Ltd - Ultrasound system, imaging, general-purpose
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. Ultrasound system, imaging, general-purpose
Single Device Product
40761 Ultrasound system, imaging, general-purpose
for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic)
body imaging procedures. It supports a wide variety of transducers and related application software
packages allowing for the collection, display and analysis of ultrasound information. Usages are, e.g.
general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler
or colour Doppler,
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:53:17 AEDT
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