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Medical Grade Pouch Form Fill Seal Machine from Japan

Cleanroom-compatible machine forming sterile pouches from medical-grade films, filling syringes/devices, and validation sealing. Classifies HTS 8422.30.91.85 unless medical instrument status applies. For pharmaceutical and device packaging.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Provide ISO 14644 cleanroom class certification

• USP Class VI validation for medical films mandatory

• Risk of dual-use classification for semiconductor cleanrooms