Medical Device Facility Registration and FURLS Listing

Get your medical device facility registered with FDA. Our specialists will assist you in getting the FDA’s Unified Registration and Listing System and Device Registration and Listing Module.

Why Medical Device Facility Registration Required?

Registering establishments (owners or operators of places of business) with the FDA annually is a must for every domestic, foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to US to provide FDA with the medical device facility establishment number for foreign drug manufacturers and importers/distributors.

Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration. Click to learn about 510(k) Medical Device Registration

What is FURLS?

FURLS is an acronym for FDA Unified Registration and Listing System. It is a system of FDA to help applicants register through the online system and make electronic submissions. With FURLs, you can view and edit your applications even after submission. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS).

Medical Device Facility Registration and FURLS Listing

Registration of Medical Device Establishment through the Unified Registration and Listing System! To register, you must submit your establishment’s registration and listings through FDA’s FURLS. Below are must-know things.

As an owner or operator, having a valid login ID and password to access the FURLS is a must

As an owner or operator, you must obtain an annual registration

In case of official correspondent, owner or operators must create a separate sub-account for any communication

FDA has established FURLS to advance electronic submissions

Medical Device Facility Registration and FURLS Listing!

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