FDA Medical Devices

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We are your trusted partner in the U.S., assisting you with FDA compliance of your medical devices. Learn more about our FDA agent and support services.

Medical devicesBased in New York, TABS is a trusted and proven U.S. partner, that can help you with the FDA compliance of the medical devices that you want to market in the U.S. We have already offered our high-quality FDA agent and support services related to product registration, facility registration, and label review for medical devices to many companies. 

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. We offer high-quality FDA agent and support services related to medical devices establishment registration, device listing, U.S. – Agent,  label review for medical devices, and assessment to help you look forward to successfully entering and navigating the U.S. market.


Medical devices

Is your product a Medical Device?

It’s your product classified as Class 1?

I am not sure.

Yes, but I need to confirm its classification.

Yes, and I am a foreign establishment and I need an U.S.-Agent for registration and listing purposes.

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