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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...more


  • Update to MEDDEV Guidelines...more

  • Update Harmonized Standards

    EN 980 is back...more



    
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"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

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"The NEW CE MARKING"
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Cosmetic Products in Europe

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重要事件
Join us!

- 2018德国汉诺威,业内研讨会   
盟新CE认证"   





Meet us!

- 2018年11月12日至15日
在德国杜塞尔多夫专业医疗展会MEDICA
展位#10B05号





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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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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.