Contec Medical Systems Co., Ltd. · 89-08 · CHINA

For Contec Medical Systems Co., Ltd., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories | All models of patient monitors and their accessories; product code is 68 N - - 99 Small Hospital Practice Equipment, NEC (Nonhuman) | 68 Z - - 99 Animal Medical Devices, NEC | 73 B - - ZQ Monitor, Breathing Frequency | 73 C - - CK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 73 D - - QA Oximeter | 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 74 D - - SI Detector And Alarm, Arrhythmia | 74 D - - SK Computer, Blood-Pressure | 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive | 74 M - - HX Monitor, Physiological, Patient | 74 M - - LD Monitor, St Segment with Alarm | 80 F - - LL Thermometer, Electronic, Clinical; date published is 01/24/2025; address is Economic And , No. 112 Qinhuang West Street; Technical Development Zone , Qinhuangdao, Hebei CHINA, verified against its source on 2026-09-30.

What the source says

Contec Medical Systems Co., Ltd. Date Published : 01/24/2025 Economic And , No. 112 Qinhuang West Street; Technical Development Zone , Qinhuangdao, Hebei CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.