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Holter Monitor from Japan

A portable electrocardiogram (ECG) device worn by patients to continuously record heart activity over 24-48 hours. It falls under HTS 9018.90.75 as an electro-medical instrument used in medical diagnostics for detecting cardiac arrhythmias. The device includes electrodes, recorder, and analysis software.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Obtain FDA 510(k) clearance documentation prior to import as it's a Class II medical device

• Include detailed technical specifications and biocompatibility certificates to avoid classification disputes

• Verify electromagnetic compatibility (EMC) testing compliance for electro-medical apparatus