Summary for ARTG Entry:
Lithostar Pty Ltd ATF The Mansell Family Trust - Electromechanical lithotripsy system, extracorporeal
ARTG entry for
Medical Device Included Class IIb
Lithostar Pty Ltd ATF The Mansell Family Trust
58 Mintaro Parade,QUINNS ROCKS, WA, 6030
ARTG Start Date
Medical Device Class IIb
- 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.
Dornier MedTech GmbH
Argelsrieder Feld 7
Wessling, , D 82234
1. Electromechanical lithotripsy system, extracorporeal
Single Device Product
18415 Electromechanical lithotripsy system, extracorporeal
The intended purpose of this device is to send non - invasive shock waves from outside the body in order
to fragment or pulverize stones that have developed within the body allowing them to pass from the body
as sand sized fragments during natural excretion
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:04:10 AEDT
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