Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Vatech Medical Pty Ltd - Hand-held intraoral dental x-ray system, digital
ARTG entry for
Medical Device Included Class IIb
Vatech Medical Pty Ltd
Suite 5.04 Gateway Business Park, 63-79 Parramatta Road,Silverwater, NSW, 2128
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.
Vatech Co Ltd
13 Samsung 1-ro 2-gil
Hwaseong-si, Gyeonggi-do, 18449
Korea - Republic of
1. Hand-held intraoral dental x-ray system, digital
Single Device Product
44606 Hand-held intraoral dental x-ray system, digital
A diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption
pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the
diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity
structures. It is designed to be easily carried from location to location by a single operator. The sensor is
placed in the mouth, the purpose being to visualize a limited region in detail.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:44:10 AEDT
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