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Fresenius 4008S Hemodialysis Machine from Germany

The Fresenius 4008S is a hemodialysis machine designed for in-center and acute care dialysis treatments, featuring advanced fluid management and monitoring systems. It falls under HTS 9018.90.75.20 as a complete dialysis instrument used to filter blood for patients with kidney failure. This electro-medical apparatus includes pumps, dialysate preparation, and safety sensors specific to dialysis procedures.

Duty Rate — Germany → United States

10%

Rate breakdown

9903.05.3910%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.97, articles the product of a member state of the European Union, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 10 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Obtain FDA 510(k) clearance and ensure device listing prior to import; verify biocompatibility per ISO 10993 standards

• Include detailed technical files, user manuals, and sterilization validation documents in shipment paperwork

• Avoid misclassification as general pumps (8413); highlight dialysis-specific blood and dialysate circuits