Summary for ARTG Entry:
AMBU Australia Pty Ltd - Electrosurgical diathermy system return electrode, single-use, non-sterile
ARTG entry for
Medical Device Included Class IIb
AMBU Australia Pty Ltd
2/1 Prosperity Parade,WARRIEWOOD, NSW, 2102
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.
Ballerup, , DK-2750
1. Electrosurgical diathermy system return electrode, single-use, non-sterile
Single Device Product
58494 Electrosurgical diathermy system return electrode, single-use, non-sterile
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy
generator, to create a circuit for the return of electrical current to the generator after its emission to perform
electrosurgery on the patient.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:39:00 AEDT
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