Manual blood lancing device, single-use

Australia - English - Department of Health (Therapeutic Goods Administration)

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Linear Medical Pty Ltd
Class IIa
Authorization status:
Authorization number:

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Public Summary

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

Postal Address

Unit D,5 Jubilee Ave,Warriewood, NSW, 2102


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



61578 Manual blood lancing device, single-use

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

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Produced at 03.11.2017 at 06:01:14 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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