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HIGHLIGHTS
Keep up to date!

News and Views March 2017

New Medical Device Regulation (MDR) in Europe
Read more...

In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

8. Medical Device Networking Meeting
Hanover, April 27, 2017



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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contact us





FDA Device Registration and Listing


Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are mandated to register annually with the FDA. Most establishments that are required to register have to list the devices, functions and the activities performed on those devices. 


Registration and listing information is submitted by using FDA's Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM). An annual establishment registration user fee must be paid to the FDA for device establishment.


MDSS performs the establishment registration and device listing on the behalf of our clients.

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