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 photo and video Look forward to hearing from you soon. Show More