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Medical Devices Registration with US FDA

Duns Number registration

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What is D-U-N-S® Number ?

D-U-N-S® Number is Data Universal Numbering System, an universal numbering system with an unique 9 digital, used widely to enterprise identification, business information organization and arrangement. Duns number can help you acquire unique, abundant and high quality information product and service, has became a standards of recording universal company.

Since 1962, Duns company has starting identification works of universal company. Up to now, over 100 million has accepted the identification service. Since 1998, Duns has cooperated with US FAR to identify company. Currently, FDA employs Duns company identification service, authorizes Duns as the only identification.

Why do we need to provide DUNS number when FDA registration ?

Because DUNS is one of company information that FDA require foreign company should provide when they apply FDA registration.

When you have DUNS code, FDA could know the exact address and legal identification. Such as medical devices, food, drug, and tobacco, FDA will require DUNS number to be provided.

Who else use DUNS number ?
Since invention in 1962, DUNS number has been used more and more widely, and more and more organizations has use DUNS as identification standards.

America National Standard institute (ANSI ASC X12)) - since 1999
The United Nation - since 1991
European Commission
National Standard Body - since 1993
America Federal Government
Electronic Commerce and Purchase organization - since 1994
Federal Energy Regulatory Commission
United States Postal Service
North America Free Trade Agreement
Australia Government