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FDA Import Refusal K80-5154281-0/10003/1 — Contec Medical Systems Co., Ltd.

Contec Medical Systems Co., Ltd. — FEI 3006979678

The FDA refused shipment K80-5154281-0/10003/1 from Contec Medical Systems Co., Ltd. (China) on December 4, 2025. The refused product falls under Devices — OXIMETER. Cited charge: 2780 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 4, 2025
Country
China
Product Category
Devices
Product Code
73DQA OXIMETER
Charges
2780

Recent inspections

  • 1274346 (OAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1251944 (NAI Thu Sep 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 919269 (NAI Thu Mar 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787444 (NAI Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

FDA data resources