3904.61.00.10/PTFE Granules for Medical Grade Applications/Japan

PTFE Granules for Medical Grade Applications from Japan

USP Class VI compliant granular PTFE, unfilled and biocompatible for molding medical device components like implants. Meets HTS 3904.61.00.10 as pure granular primary fluoropolymer. Sterilizable and low extractables.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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Import Tips

• Include USP certification and biocompatibility test reports; segregate for FDA import alert avoidance

• Pitfall: incorrect medical device classification under 9018