Summary for ARTG Entry:
Merz Australia Pty Ltd - Belotero Balance 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 Balance 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 buffer. Contains 0.3% lidocaine hydrochloride. Pack contains 1 sterile
27G½" needle and 1 sterile 30G½" needle.
An injectable resorbable filler implant indicated to fill moderate facial wrinkles and folds as well as for lip
enhancement. It is also suitable for correction of facial atrophic scars. The presence of lidocaine reduces
local pain associated to the injection of the gel and improves patient's comfort during and immediately after
Volume (mL) 0.6 and 1.0
No Specific Conditions included on Record
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