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FDA Medical Device Registration Assistance

U.S. FDA Medical Devices Registration and FDA Device Listing

Register your medical device establishment with the U.S. FDA and list your devices for commercial distribution in the U.S. market. FDA Listing Inc. can act as your U.S. FDA Agent and provide expert guidance on FDA regulations.

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U.S. FDA Global Device Identification GUDID Unique Device Identifiers UDI

Ensure FDA GUDID-UDI Compliance for Medical Devices by submitting device information to the FDA Global Unique Device Identification Database (GUDID) to obtain the UDI with the help of FDA Listing Inc.

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FDA Medical Device Labeling Requirements

Meet the FDA Medical Devices labeling requirements and stay compliant with the help of FDA Listing Inc.'s expert label review.

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FDA 510k Preparations and Submissions

Streamline your 510(k) submission process with FDA Listing Inc.'s 510(k) filling preparation services.

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FDA Color Additive Requirements

U.S. FDA strictly regulates the color additives that are being used in any part of the manufacturing process of medical devices . All color additives must be properly declared on the product labels. Use of unapproved color additives violates FDA regulations.

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FDAListing.com Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.
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U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info