Summary for ARTG Entry:
Medical & Optical Instruments Australia Pty Ltd - Electrode, electrosurgical, active, hand-controlled, single
ARTG entry for
Medical Device Included Class IIb
Medical & Optical Instruments Australia Pty Ltd
PO Box 850,ARTARMON, NSW, 1570
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.
Zhejiang Shuyou Surgical Instrument Co Ltd
Anji Economic Development Zone Health
Medicine Industrial Park
Huzhou City, Zhejiang Prov, 313300
1. Electrode, electrosurgical, active, hand-controlled, single use
Single Device Product
35044 Electrode, electrosurgical, active, hand-controlled, single use
An electrical conductor that provides an electrical connection (possibly in conjunction with a cable)
between an electrosurgical generator and a patient The electric power switch for this device is an integral
part of the electrode, allowing its operation by the surgeon's hands. This device is typically in the form of a
pen or pencil This device is used for cutting or coagulation in both open and Laparoscopic Surgery. Single
No Specific Conditions included on Record
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Produced at 10.11.2017 at 12:51:21 AEDT
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