The documents below are needed： 1.Business license of the supplier 2.Manufacturing license agreement 3.Product sales license registration certificate for medical device 4.Report for detecting and analyzing test report 5.Product safety commitment 6.Product test report ( either one as below shown) a) US：ASTM F2100-2018 level2、3；FDA Show More...
The documents below are needed： 1.Business license of the supplier 2.Manufacturing license agreement 3.Product sales license registration certificate for medical device 4.Report for detecting and analyzing test report 5.Product safety commitment 6.Product test report ( either one as below shown) a) US：ASTM F2100-2018 level2、3；FDA 510K b)Europe：EN14683-2014 IIR c)Japan：JIS T8062:2010 d)Korea：KS K ISO 22609 e)International ：ISO 22609:2005 f)China mainland：YY0469-2011；GB19083-2010；YY T0969-2013 7. Product, factory to and video Look forward to hearing from you soon.
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