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Welch Allyn CardioPerfect ECG Workstation from Japan

A digital electrocardiograph system that records and analyzes heart electrical activity using 12-lead electrodes. It connects to computers for real-time waveform display and automated interpretation, classified under HTS 9018.11.30.00 as an electrocardiograph for clinical diagnostic use.

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

• Ensure FDA 510(k) clearance and Class II device registration before import

• Include calibration certificates and validate software for regulatory compliance

• Avoid misclassification as general electro-medical apparatus by documenting 12-lead ECG functionality