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  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
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  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...
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THE "NEW" CE MARKING
Get your questions answered for the NEW REGULATION 
– THE MDR/IVDR!!!

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



Cosmetic Products in Europe

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EVENTS
Meet us!

Arab Health
January 29-01 February, 2018
Dubai
Booth #Z3.D19


MD&M West
February 06-08, 2018
Anaheim, CA, USA
Booth #1969


Join us!

MDSS Workshops
Medizinprodukteverordnung (MPV)
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CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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contact us





Medical Devices registration in the USA: FDA-Registration and Listing


Manufacturers and distributors placing on the market or distributing medical devices in the United States of America for commercial purposes are required to register them with the FDA

The companies  required to register, have to list their devices, their functions and activities performed using these devices and update them once a year. Registration and listing information is submitted using FDA's Unified Registration and Listing System (FURLS) or the Device Registration and Listing Module (DRLM). 

For product registration with the FDA, the companies have to pay an annual user fee. MDSS Consulting GmbH performs the establishment registration and device listing on the behalf of our clients.

We would also be happy to support you if you want to place your products on the US-American market for the first time. We will advise you on which is the correct registration procedure for your product.


OUR CONSULTING SERVICES IN OVERVIEW