23/12/2022 Other Services
If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance are not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list their products.
ITB HOLDINGS LLC
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Orlando, FL 32801
United States
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https://www.fda.itbhdg.com/product/medical-devices/
ITB HOLDINGS LLC as your company’s FDA U.S. Agent for: Cosmetic Establishment Registration Drug Establishment Registration Medical Device Establishmen...
All establishments must pay the medical device establishment registration User Fee. There are no waivers or reductions for small establishments, busin...
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the...
If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance i...
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