Summary for ARTG Entry:
Fujifilm Australia Pty Ltd - Catheter, bronchial 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, bronchial balloon
Single Device Product
17827 Catheter, bronchial balloon
This product is used to seal the acoustic coupling medium when using an Ultrasonic Endoscope under the
management of a physician in medical facilities.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:57:39 AEDT
This is not an ARTG Certificate document.
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