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FDA Import Refusal 98K-2250446-0/10002/1 — Woorhi Mechatronics

Woorhi Mechatronics — FEI 3010126182

The FDA refused shipment 98K-2250446-0/10002/1 from Woorhi Mechatronics (South Korea) on August 13, 2025. The refused product falls under Devices — POWERED MICRONEEDLE DEVICE. Cited charges: 3904,3905,508 This firm has 4 other import refusals on record.

Refusal Details

Date
August 13, 2025
Country
South Korea
Product Category
Devices
Product Code
79QAI POWERED MICRONEEDLE DEVICE
Charges
3904,3905,508

Other import refusals

  • 98K-2254337-7/10002/1 (Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 98K-2250446-0/20002/1 (Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 98K-2249373-0/12/1 (Fri May 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-8620949-4/11/1 (Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources