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Bionet CardioTouch 3000 ECG Interpreter from Germany

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 — Germany → United States

10%

Rate breakdown

9903.05.3910%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.97, articles the product of a member state of the European Union, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 10 percent, as provided for in U.S. note 52 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