Fresenius 4008S Hemodialysis Machine from China

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 — China → United States

35%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
9903.88.0125%Except as provided in headings 9903.88.05, 9903.88.06, 9903.88.07, 9903.88.08, 9903.88.10, 9903.88.11, 9903.88.14, 9903.88.19, 9903.88.50, 9903.88.52, 9903.88.58, 9903.88.60, 9903.88.62, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(a) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(b) [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