Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Linear Medical Pty Ltd - Manual blood lancing device, single-use
ARTG entry for
Medical Device Included Class IIa
Linear Medical Pty Ltd
Unit D,5 Jubilee Ave,Warriewood, NSW, 2102
ARTG Start Date
Medical Device Class IIa
- 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.
SteriLance Medical Suzhou Inc
no 68 Litanghe Road
Xiangcheng, Suzhou, 215133
1. Manual blood lancing device, single-use
Single Device Product
61578 Manual blood lancing device, single-use
A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a
capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a
diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a
manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined
depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:01:14 AEDT
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