Food and Drug Administration and state and local regulatory agencies. Reprocessing will be required before patient use. It is up to the purchaser to meet all requirements and regulation certification processes that deemed necessary per FDA or any other regulatory agencies that may be applicable.This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Other Healthcare, Lab & Dental". The seller is "monar_8587" and is located in this country: US. This item can be shipped worldwide.