Summary for ARTG Entry:
INKA Surgical - Electrode, electrosurgical, active, hand-controlled, reusable
ARTG entry for
Medical Device Included Class IIb
116 Cutler Road,JANDAKOT, WA, 6164
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.
Bema GmbH & Co KG Endochirurgische
Rudolf Diesel Strasse 5
, Emmingen, 78576
1. Electrode, electrosurgical, active, hand-controlled, reusable
Single Device Product
42552 Universal hand-controlled electrosurgical diathermy system conducting unit, reusable
usually in the form of a pen or penicil, this electrical conductor is intended to provide an electrical
connection in conjuction with a cable betwen a patient and an electrical generator theirfor producing and
electrosurgical effect. an important part of the device is the power switch which allows its operation by the
No Specific Conditions included on Record
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