Wellkang® LLC
February 11, 2002:
The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.

December 12, 2003:
All foreign food facilities must include the name of a “US Agent” with their registration with FDA.

Wellkang LLC is your reliable “US Agent” registered with FDA for both Medical Devices & Foods.

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  CE Marking Service:
  • Help non-EU manufacturers to get CE Marking for their products' entering the European market.
  • European Authorized Representative to non-EU manufacturers as required by EU&EFTA regulations.

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    CCC Mark Service:
    Providing services to worldwide manufacturers who need CCC Mark (China Compulsory Certification) for their products' entering into and/or being freely circulated in the China market.

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      U.S. FDA Issues:

  • "US Agent" Service:
          Acting as the "US Agent", we represent non-US medical device manufacturers as well as food manufacturers, as required by FDA regulations.

  • 510(k) Premarket Notification:
          Submitting, on behalf of the medical device manufacturers, 510K notifications to FDA to clear products into the US market.
          Many of FDA regulated devices fall under the medium risk (usually class 2), requiring 510k clearance letter PRIOR TO marketing the product in US. FDA's clearance letter is required before any manufacturer can market/sell a medical device in US market (unless the device is exempt). Besides, the 510k clearance letter may also be used as a marketing tool for countries other than the US.
          Click to learn about  510k Submission Procedure ...

  • Compliance Consulting:
           Resolution of FDA 483 and warning letters, import and export problem solving.

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