Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
The Dentist's Workshop - Stationary intraoral dental x-ray system, digital
ARTG entry for
Medical Device Included Class IIb
The Dentist's Workshop
Po Box 73,Mount Evelyn, VIC, 3796
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.
Zhuhai Siger Medical Equipment Co Ltd
Building 2 No 1 Chuangxin Yi Road Tangjiawan
Zhuhai City, Guangdong, 519080
1. Stationary intraoral dental x-ray system, digital
Single Device Product
42297 Stationary intraoral dental x-ray system, digital
This is a diagnostic dental x-ray system that is in a fixture position within a dental clinic that is intended to
be used to generate and control x-ray beams that records the absorption pattern of x-ray beams used for
general-purpose, routine, dental radiography examinations involving the diagnosis and treatment of
diseases of the teeth, jaw and oral cavity structures.
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Produced at 02.11.2019 at 07:19:55 AEDT
This is not an ARTG Certificate document.
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