根据美国FDA要求，凡向美国市场出口医疗器械成品、半成品的制造商（含OEM加工商），应在美国FDA系统进行企业注册。
企业注册成功后，会获得Registration Number, FEI Number和Owner/Operator Number.
FDA医疗器械企业注册流程为：
Parent Company：
Shenzhen Reanny Medical Device Management Consulting Co.,Ltd
Address：Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen
Guangzhou Branch：
Guangzhou Reanny Medical Device Consulting Co., Ltd
Address：No. 2205, West Block, Building K, Kehui Jingu, No. 99, Kexue Avenue, Huangpu District, Guangzhou
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