Summary for ARTG Entry:
Terumo Australia Pty Ltd - Generator, lesion, radio frequency
ARTG entry for
Medical Device Included Class IIb
Terumo Australia Pty Ltd
PO Box 312,NORTH RYDE BC, NSW, 1670
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.
Shanghai AngioCare Medical Technology Ltd
590 Ruiqing Road Building 6 Suite 301
East Zhangjiang High-Tech Park, Shanghai,
1. Generator, lesion, radio frequency
Single Device Product
35156 Radio-frequency ablation system generator
The Iberis Radio Frequency Generator is intended to deliver radio frequency energy for renal denervation
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:55:18 AEDT
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