Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Aurora BioScience Pty Ltd - Oral mucositis cryotherapy mouthpiece
ARTG entry for
Medical Device Included Class 1
Aurora BioScience Pty Ltd
PO Box 946,BAULKHAM HILLS, NSW, 2153
ARTG Start Date
Medical Device Class 1
- 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.
Chemo Mouthpiece LLC
10 Railroad Avenue
Closter, New Jersey, 07624
United States Of America
1. Oral mucositis cryotherapy mouthpiece
Single Device Product
64345 Oral mucositis cryotherapy mouthpiece
Chemo Mouthpiece is an intraoral cryotherapy device intended to help reduce swelling and discomfort.
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Produced at 02.11.2019 at 07:26:05 AEDT
This is not an ARTG Certificate document.
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