Shenzhen Comen Medical Instruments Co., Ltd.
Shenzhen Guangdong, CN
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Shenzhen Comen Medical Instruments Co., Ltd. between 2018 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) | MHX | Substantially Equivalent | |
| K250190 | Sequential Compression System (SCD600) | JOW | Substantially Equivalent | |
| K211619 | Multi-Parameter Patient Monitor | MHX | Substantially Equivalent | |
| K191106 | C50 and C80 Multi-parameter Patient Monitor | MHX | Substantially Equivalent | |
| K173454 | Multi-parameter Patient Monitor, models C30 | MHX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008716327 | 3008716327 | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. | Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, Shenzhen Guangdong 518106 CN | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- GXYElectrode, Cutaneous
- OLWIndex-Generating Electroencephalograph Software
- FTDLamp, Surgical
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- DSBPlethysmograph, Impedance
- JOWSleeve, Limb, Compressible
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain