医疗器械企业注册

美国食品药品管理局（FDA）现代化法案要求所有从事生产、配制、传播、合成、组装、加工或进出口医疗器械的企业必须在FDA进行注册并同时递交美国代理信息。

美国代理人

非美国公司必须向FDA提交与FDA联络的美国代理的名称，地址和电话号码。以确保后续 FDA能够及时联系到美国代理，并传达重要通信

证书

已经在美国FDA注册的公司，经常被其客户或供应商要求核准其美国FDA注册真实有效。

我们可以协助贵司出具FDA证书，用于侧面证明其注册在美国FDA真实有效。FDA官方从不颁发任何证书。

510K申报

"510(k)" – 又称上市前通知(PMN)，根据食品、药品和化妆品(FD&C)行动委员会和21 CFR 807的510(k)规章，任何想在美国出售医疗器械的单位都要求在器械上市之前至少90天递交510(k)申请。510(k)文件是向FDA递交的上市前申请文件，目的是证明申请上市的器械与不受上市前批准(PMA)影响的合法上市器械同样安全有效，即为等价器械(substantially equivalent)。申请者必须把申请上市的器械与现在美国市场上一种或多种相似器械对比，得出并且支持等价器械的结论。

如需要判定产品是否属于510K，请联系我们。

医疗器械标签审核

我们的专家可以提供医疗器械的标签审核和设计，以便帮助企业满足FDA的标签要求。

GUDID

UDI即Unique Device Identifier，器械唯一识别符，指满足CFR part 830.20要求的，通过其分销和使用来充分识别一个器械的一种识别符。UDI是一种数字或字母编码，由两部分组成，分别为器械识别符(device identifier, DI)和生产识别符(production identifier, PI)。

邓白氏号码申请

邓白氏号码（D-U-N-S® Number是Data Universal Numbering System的缩写）是一个独一无二的9位数字全球编码系统，被广泛应用于企业识别、商业信息的组织及整理。邓氏编码可以帮助您迅速获得独创的，丰富而且高质量的信息产品和服务。

自2010年起，FDA规定医疗器械及医药企业办理FDA注册时，必须先取得邓白氏号码（也称邓氏号码,DUNS号码）。后续食品企业也需要申请邓白氏号码。

如您需要，我们会免费帮您获得邓白氏号码。

Medical device registration and listing

FDA requires the firms that participate in manufacturing, distribution and other related activities of medical device for marketing in the United States to register the establishment annually and pay the registration fee. The establishments are required to complete annual registration between October 1 and December 31 each year.

Medical Device US Agent

The foreign establishment that manufactures, processes or conducts related activities of the medical device that are sold in the United States are required by FDA to identify a United States agent (U.S. agent) during establishment registration.

Medical Device Certificate

BES consulting register your medical device facility and provide you with our trusted Certificate of Registration.

510K Submission

Medical device companies that want to market their products in US can submit 510(k) Premarket Notification to demonstrate that the new product is substantially equivalent to a "predicate device". Once FDA determines that the new product is at least safe and effective as the predicate device, the new product can be marketed in US

Medical Device Label Review

BES consulting helps medical device company to comply with FDA labeling regulations and assist with labeling preparation. The regulations are intended to inform the customers of the product's intended use, warning, ingredients, net quantity of contents, and information of manufacturer, packer or distributor. They also protect customers from hazards, and prohibit against false or misleading information.

D‑U‑N‑S Number

The Dun & Bradstreet D-U-N-S Number is a unique nine-digit identifier for businesses. We can assist with it for free.