FDA注册中心,具备丰富的FDA服务经验,协助了各国许多经营食品及接触材料、药品、海鲜、化妆护肤品、医疗器械等进出口业务的公司，成 功的把商品打入美国市场，并解决了各类产品被扣留、被拒绝的疑难问题。协助企业遵守美国食品与药品管理局（FDA）的标准，签发的注册证书为企业提供已履 行FDA注册要求的证明。FDA不发放或确认注册证书，欧标检测并非FDA的附属机构。
The FDA Registry, with rich experience in FDA services, has assisted many companies in the import and export business of food and contact materials, pharmaceuticals, seafood, cosmetics and skin care products, medical devices, etc. in many countries, successfully bringing commodities into the American market and solving the difficult problems of various products being detained and rejected. Assist enterprises to comply with FDA standards, and issue registration certificates to provide enterprises with evidence that they have fulfilled FDA registration requirements. FDA does not issue or confirm registration certificates, and Euro-standard testing is not an affiliate of FDA.
医疗器械美国FDA设施(企业)注册
Medical Devices FDA Facilities (Enterprises) Registration
根据美国联邦法规21 CFR part 807章节的要求，涉及生产和分销用于在美国进行商业分销的医疗器械的企业都必须每年向美国食品药品监督管理局(FDA)进行注册。注册的过程称之为工厂 注册(Establishment Registration)；同时，这些企业必须向FDA确认他们进行商业分销的医疗器械，包括仅用于出口的器械，这个过程称之为医疗器械列示 (Medical Device Listing)。
According to section 21CFR Part 807 of the Federal Regulation of the United States, enterprises involved in the production and distribution of medical devices for commercial distribution in the United States must register with the Food and Drug Administration (FDA) every year. The process of registration is called Establishment Registration. At the same time, these companies must confirm to FDA that they are commercially distributing medical devices, including those for export only. This process is called Medical Device Listing.
自2002年2月11日起，所有的美国境外的企业必须在进行工厂注册时向FDA指定一个美国代理人(US AGENT)的联系方式。
Since Februaryall enterprises outside the United States have to appoint an American Agent (US AGENT) to the FDA when they register their factories.
关于美国FDA授权代理人的相关信息请点击--> 美国FDA授权代理人介绍
For information about FDA authorized agents in the United States, please click on - > Introduction of FDA authorized agents in the United States
注意：根据美国FDA法规，只有美国FDA授权代理人机构需要位于美国境内。任何不在美国境内的机构或个人不能直接提供美国FDA授权代理人服务。请企业注意鉴别。
[Note: According to FDA regulations, only authorized agencies of FDA in the United States need to be located in the United States. No agency or individual outside the United States can directly provide FDA authorized agency services. Please pay attention to identification. ]
我们提供的医疗器械美国FDA设施(企业)注册服务包括：
We provide FDA facility (enterprise) registration services for medical devices in the United States, including:
1) 完成产品完成分类，判定其注册途径；
1) Complete product classification and determine the way of registration;
2) 为您向FDA申请支付工厂注册年费；
2) Apply to FDA for annual fee of factory registration.
3) FDA工厂注册年费代理支付；
3) FDA factory registration annual fee agent payment;
4) 为您完成工厂注册和医疗器械列示；
4) Complete factory registration and list of medical devices for you;
5) 向您提供美国FDA授权代理人(U.S. Agent)服务。
5) Provide you with U.S. FDA Authorized Agent service.
目前我们的FDA申请通过率一直保持在100%，我们承诺申请不成功，我们全额退款
At present, our FDA application approval rate has been maintained at 100%. We promise that the application is unsuccessful and we will refund it in full.