# Contec Medical Systems Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Contec Medical Systems Co., Ltd. · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.

- **Firm:** Contec Medical Systems Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Economic And , No. 112 Qinhuang West Street; Technical Development Zone , Qinhuangdao, Hebei CHINA _(verified: appears in the quote below)_
- **Date published:** 01/24/2025 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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 68 N - - 99 Small Hospital Practice Equipment, NEC (Nonhuman) Date Published: 02/25/2025 Desc: All models of patient monitors and their accessories Notes: 68 Z - - 99 Animal Medical Devices, NEC Date Published: 02/25/2025 Desc: All models of patient monitors and their accessories Notes: 73 B - - ZQ Monitor, Breathing Frequency Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 73 C - - CK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 73 D - - QA Oximeter Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 D - - RT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 D - - SI Detector And Alarm, Arrhythmia Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 D - - SK Computer, Blood-Pressure Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 D - - XN System, Measurement, Blood-Pressure, Non-Invasive Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 M - - HX Monitor, Physiological, Patient Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 74 M - - LD Monitor, St Segment with Alarm Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes: 80 F - - LL Thermometer, Electronic, Clinical Date Published: 01/24/2025 Desc: All models of patient monitors and their accessories Notes:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).