3004.31.00.00/Tresiba FlexTouch Insulin Pen/Canada

Tresiba FlexTouch Insulin Pen from Canada

Tresiba FlexTouch provides ultra-long-acting insulin degludec for diabetes basal insulin therapy. Available in U100 (3mL, 100 units/mL) and U200 (3mL, 200 units/mL) pre-filled pens with measured dosing. Falls under HTS 3004.31.00.00 as retail-packaged insulin medicaments.

Duty Rate — Canada → United States

100%

Rate breakdown

9903.04.60100%Pharmaceuticals: patented pharma articles — 100% floor rate

9903.05.860%Universal product exemption (U.S. note 52(b))

9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)

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Import Tips

• Dual concentration variants need separate line items with precise strength declaration

• EU COS certificates essential for insulin biologics import

• Pen needle compatibility docs prevent device reclassification