Home / Import refusals / 799-3511459-6/11/1

FDA Import Refusal 799-3511459-6/11/1 — Medicore Co., Ltd.

Medicore Co., Ltd. — FEI 2000010846

The FDA refused shipment 799-3511459-6/11/1 from Medicore Co., Ltd. (South Korea) on October 22, 2024. The refused product falls under Devices — ELECTROCARDIOGRAPH FOR OVER-THE-COUNTER USE WITH OR WITHOUT ARRHYTHMIA DETECTION. Cited charges: 118,341,508 This firm has 2 other import refusals on record.

Refusal Details

Date
October 22, 2024
Country
South Korea
Product Category
Devices
Product Code
74QDA ELECTROCARDIOGRAPH FOR OVER-THE-COUNTER USE WITH OR WITHOUT ARRHYTHMIA DETECTION
Charges
118,341,508

Recent inspections

  • 1091675 (VAI Thu Apr 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 802-0036990-0/1/1 (Wed Aug 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 791-3492545-6/1/1 (Wed Dec 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources