Consulting for Medical Protective Devices – US FDA Registration & Listing

We provide Medical Gown, Coverall, Face Shield, Shoe Cover, Head Cap, Surgeon Gloves, US FDA Registration Service for those looking to export to USA. This service is only for manufactures.

More information about FDA registration and listing detailed below;
Step 1 : Make sure you have DUNS Number.
Step 2 : US Agent Appointment
Step 3 : Establishment Registration
Step 4: Verification of Labels
Step 5: Device Listing

Please contact us in case you wish to list your device in US FDA or get assistance on testing.
Lead time is just 1-2 Weeks.


CE – MDR / MDD / US FDA / MD-QMS / Trainings / Associated Services

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1121, Sun Avenue One, Near Sun Prima, 

Ambawadi, Ahmedabad-380006, Gujarat

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Tel: +91 74900 17774

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