Summary for ARTG Entry:
Digital Medics Pty Ltd - Electronic insulin pen
ARTG entry for
Medical Device Included Class IIb
Digital Medics Pty Ltd
Suite 70 377 Kent Street,SYDNEY, NSW, 2000
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.
Diamesco Co Ltd
Migun Techno World II 305 533-1
Yuseong-gu, Daejeon, 305-500
Korea - Republic of
1. Electronic insulin pen
Single Device Product
45819 Electronic insulin pen
A portable, hand-held, battery-powered device, typically in the form of a large pen, designed to be used by
a diabetic patient to subcutaneously inject a dose of insulin through a replaceable needle. A replaceable
cartridge filled with insulin is inserted into the device and typically a dial on the device is operated for
dosing; only the cartridge is discarded when the insulin is exhausted. In addition, the device is capable of
electronic memory functions such as the recording and display of the date, time, and amount of previous
doses. This is a reusable device
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:34:38 AEDT
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