Summary for ARTG Entry:
Merz Australia Pty Ltd - Belotero Volume Lidocaine - Synthetic-fluid tissue reconstructive material,
ARTG entry for
Medical Device Included Class III
Merz Australia Pty Ltd
Level 3,244 Coward street,Mascot, NSW, 2020
ARTG Start Date
Medical Device Class III
- 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.
18 Chemin des Aulx
Plan-Les-Ouates, , CH-1228
1. Belotero Volume Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic
Single Device Product
47887 Synthetic-fluid tissue reconstructive material, anaesthetic
A sterile, non-pyrogenic, viscoelastic, colourless, transparent cross-linked sodium hyaluronate gel of
non-animal origin, in a physiological phosphate buffer. Contains 0.3% lidocaine hydrochloride. Pack
contains 2 1ml syringes of gel, 2 sterile 27G1/2" needles, 2 sterile 30G 1/2" needles, 2 27G cannulae and
2 pre-hole needles.
Belotero Volume Lidocaine is an injectable resorbable implant indicated to restore facial volumes, as for
example to enhance the cheeks or the chin. The presence of lidocaine aims to reduce local pain
associated with the injection of the gel and to improve patient comfort.
Nil variant (as 1 device) Not Applicable
No Specific Conditions included on Record
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