Shenzhen Comen Medical Instruments Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 24 device types, 4 products catalogued, 5 clearances.
Shenzhen Comen Medical Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Lamp, Surgical and 22 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2012.
24device types registered with the FDA
4products catalogued under its own name
5510(k) clearances
Registration
| Registered name | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008716327 |
| FEI number | 3008716327 |
| DUNS | 529823362 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市科曼医疗设备有限公司 |
|---|---|
| Unified social credit code | 91440300738806174Y |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2 |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alarm, Blood-Pressure | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 7 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 29 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 5 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 6 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 6 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 5 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | C50 and C80 Multi-parameter Patient Monitor | 2019 | 6 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 8 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 5 |
| Computer, Blood-Pressure | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 12 |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 5 |
| Continuous Measurement Thermometer | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor, C80, C60, C50 | 2012 | 115 |
| Detector And Alarm, Arrhythmia | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 10 |
| Electrocardiograph | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor, C80, C60, C50 | 2012 | 18 |
| Electrode, Cutaneous | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 47 |
| Index-Generating Electroencephalograph Software | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 4 |
| Lamp, Surgical | Class 2 | LED surgical Light | 2017 | 6 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 9 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 | C80, C60, C50 | 2012 | 17 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor, Multi-parameter Patient Monitor,Model C30 | 2018 | 9 |
| Monitor, St Segment With Alarm | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 7 |
| Oximeter | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor, C80, C60, C50 | 2012 | 70 |
| Plethysmograph, Impedance | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor | 2019 | 5 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | NC10 Multi-parameter Patient Monitor, C50 and C80 Multi-parameter Patient Monitor, C80, C60, C50 | 2012 | 98 |
Own-Brand Listings
Clearances
5 clearances name Shenzhen Comen Medical Instruments Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250854 | 2025-12-17 | MHX | Traditional | This company |
| K250190 | 2025-12-08 | JOW | Traditional | This company |
| K211619 | 2022-12-29 | MHX | Traditional | This company |
| K191106 | 2019-12-13 | MHX | Traditional | This company |
| K173454 | 2018-08-16 | MHX | Traditional | This company |
| K112877 | 2012-11-07 | MWI | Traditional | Goldway (Us), Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Ventilators, Patient monitors, Anesthesia machines, Defibrillators, Neonatal care equipment |
| Export markets | 190+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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