Manual blood lancing device, single-use

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
02-11-2017

可用日期:

Linear Medical Pty Ltd

类:

Class IIa

厂商:

SteriLance Medical Suzhou Inc no 68 Litanghe Road, Xiangcheng, Suzhou, 215133 China

治疗领域:

61578 - Manual blood lancing device, single-use

疗效迹象:

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.

授权状态:

A

授权日期:

2017-08-22

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