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Fresenius 4008S Hemodialysis Machine from Japan

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 — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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