Bionet CardioTouch 3000 ECG Interpreter from China
Bionet CardioTouch 3000 is a portable ECG machine with AI-based interpretation for rapid cardiac diagnosis. It qualifies under HTS 9018.19.95 for other electro-diagnostic apparatus used in functional heart examinations.
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
• Submit software as medical device component under FDA guidance; ensure IEC 60601-1 safety certification; pitfall is undervaluing due to portable design