Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Dilator, nasal
ARTG entry for
Medical Device Included Class 1
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Provent Sleep Therapy LLC
125 Tolman Avenue
Leominster, MA, 01453
United States Of America
1. Dilator, nasal
Single Device Product
11260 Dilator, nasal
Provent Sleep Apnea Therapy is indicated for the treatment of obstructive sleep apnea (OSA).
No Specific Conditions included on Record
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Produced at 01.12.2017 at 11:27:56 AEDT
This is not an ARTG Certificate document.
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