U.S. FDA Medical Device Establishment Registration and Listing


All establishments involved in the production and distribution of medical devices for commercial distribution in the United States, including those imported solely for export, must register with the FDA annually.

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Help companies register and list the medical device correctly.

After submitting your 510(k), you need to register with the FDA. As a professional service platform, your trusted partner, our company provides U.S. FDA medical device establishment registration and listing services to medical device manufacturers, guiding and assisting your company to complete the registration and listing with U.S. FDA.

U.S. FDA Medical Device Establishment Registration and Listing

Who Must Register, List and Pay the Fee?

FDA has divided into two groups of establishments which is domestic and foreign establishments. In general, if you are a manufacturer of medical device must register and list the device. However, except for initial importer do not need to register but also the companies require listing device to the FDA.

The initial importer is who responsible for furthers the marketing of a device from a foreign manufacturer to the final distributor for sale device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

For more detailed information please refer to the FDA website here.

How Can Our Company Help You to Register and List Medical Device to the FDA?

All register and listing must submit electronically to the FDA online FURLS system. You can complete the registration by yourself, please read the FDA website. 

However, to avoid the process confusion, our company can assist you to complete the process correctly. We will:

  • Set up an account ID to use FURLS if your product is new to the U.S market.
  • Help make payment and obtain Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website. It is necessary step before the registration process.
  • Complete and review all registration information is correct before submit.
  • List device to the FDA Device Registration and Listing Module (DRLM).

If you have never registered any medical device product, we can assist you in evaluating the classification and selecting the appropriate product code according to your needs.

Registering your company with the FDA and listing your devices is a necessary step for your product to launch and sell on the U.S. market. Our company has multiple experiences and smooth communication with the FDA, as well as is familiar with the regulatory requirements of FDA medical devices, which can significantly improve your registration and listing efficiency and accelerate your product's push to market. If you need help or have a question, please feel free to contact us for more details.

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