Welch Allyn CardioPerfect ECG Workstation from China

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 — 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

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