Summary for ARTG Entry:
Fujifilm Australia Pty Ltd - Catheter, gastrointestinal balloon
ARTG entry for
Medical Device Included Class IIa
Fujifilm Australia Pty Ltd
PO Box 57,BROOKVALE, NSW, 2100
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.
26-30 Nishiazabu 2 Chome
MINATO KU TOKYO, , 106 8620
1. Catheter, gastrointestinal balloon
Single Device Product
45712 Catheter, gastrointestinal balloon
This is a balloon intended to be used in combination with Endoscope, assists insertion of Endoscope into
the small intestine at a medical facility under the management of a physician. This product is not intended
for use for any child or baby.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:57:23 AEDT
This is not an ARTG Certificate document.
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