We are consultants and US Agents helping manufactures, Exporters and Importers of Medical Device to sell there Medical Device In U.S.A. from across the globe.

The main services we provide include proper guidance, Registration, Listing and US Agent service. Readers are requested to read more about USFDA Medical Device Regulation before starting the activities.


  • Make sure either the device is 510k exempted or you hold a valid 510k Number to proceed with Registration activities.
  • If you are an Initial Distributor or Reseller, make sure manufacturer has already Listed the devices.

Below table explains the step by step simple process in detail.





Appoint US FDA Agent

449 USD


Submit the Application Form online
  Need Expert Assistance? We charge 100 USD additional



FDA Annual Fee for the Year 2019 [ to be paid directly to FDA]

4884 USD


We will Complete the registration, Listings and Issue Agent Certificate.


Verify the Registration and Listing Details in FDA website
[ Type your company name in the establishment name column provided]

For payment and Invoice please write to


Frequently asked Questions

1. What you mean by expert guidance? For how long?

Our company experts will study, understand your Medical Device planning to launch in USA Market. Guide you correctly considering all the possible errors which can happen during filling. Our support ends with successful submission of Application Form till Facility Registration and Listing is over.

2. U S Agent Fees of 500 USD includes Listing also?

Yes, 500 USD includes 2 medical devices listing absolutely free. Additional medical devices will be charged 50 USD each.

3. How can I register and List, if my device is not cleared 510k?

It is not possible to to complete Establishment Registration. You must have atleast one 510k cleread or exempted device for FDA registration.

4. How can I make payment for listing more than 2 Nos.?

Once you submit the form, Our experts will cross verify and if found more number of devices for Listing we will send intimation/invoice or chek for various payment options.

5. How long it will take to complete the Medical Device registration and Listing process? When I can sell the product in USA?

2-3 weeks. Once FDA assigns the owner-operator number and Listing is completed, you can start marketting the medical devices in USA.

More information

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+49 2161 990 8831
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