Safety Lancets Manufacturer - What is the testing standard used for lancets?

H

Hello - 2006

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My company is a newly established Medical Devices manufacturer. We are currently looking to produce Safety Lancets for US, Europe and China market. I would like to know anybody got any idea what is the testing standard used for lancets, and do we need to carry out biocompatibility study as it is a Class I product in FDA list?

Thank you in advance. :eek:
 
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