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Foley Indwelling Urinary Catheter from China

A flexible rubber tube inserted into the bladder to drain urine continuously, featuring an inflatable balloon to secure it in place. Classified under HTS 9018.39.0020 as a rubber catheter used in medical and surgical procedures for urinary management. Made primarily from natural or synthetic rubber for biocompatibility and flexibility.

Duty Rate — China → United States

12.5%

Rate breakdown

9903.05.3112.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of China, as provided for in U.S. note 52 to this subchapter

Import Tips

• Ensure FDA 510(k) clearance documentation and biocompatibility testing certificates (ISO 10993) are included in shipments

• Label with lot numbers, sterilization method (e.g

• EO or gamma), and size (French scale) to meet medical device reporting requirements

• Avoid misclassification as general rubber tubing (4016); verify medical end-use with affidavits to prevent audits