3004.31.00.00/Levemir FlexTouch Insulin Pen/Germany

Levemir FlexTouch Insulin Pen from Germany

Levemir FlexTouch delivers insulin detemir, a long-acting basal insulin analog for diabetes glycemic control. Each 3mL cartridge (100 units/mL) in the pen allows precise measured dosing for retail patient use. Classified in 3004.31.00.00 as insulin hormone medicament in measured retail form.

Duty Rate — Germany → United States

15%

Rate breakdown

9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% 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

• Biosimilar insulins need additional FDA abbreviated new drug application data for import

• Declare pen mechanism separately if reusable; only disposable pre-filled units stay in 3004

• Cold chain validation critical—thermal mapping data prevents 'adulterated' FDA holds