USA

"US Agent" Service:

Acting as your "US Agent", we represent non-US medical device manufacturers as required by FDA regulations.

510(k) Premarket Notification:

Preparation and submission of  510(k) notifications to FDA for marketing clearance.  FDA's clearance letter is required before any manufacturer can market/sell a medical device in US market (unless the device is exempt).

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Contact

ECURAC - EU / China / US Regulatory Affairs Consultants European Union
+49 89 21550998
China
+86 131 6119 7082
United States
+1 805 570 6135