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Shenzhen Comen Medical Instruments Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances

Name: Shenzhen Comen Medical Instruments Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Comen Medical Instruments Co., Ltd. is registered with the FDA (registration 3008716327) in Shenzhen Guangdong, China. It lists 24 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 29, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008716327
Address: Floor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2 FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, 518106, Guangdong, Shenzhen Guangdong, China, 518106
Owner or operator: Shenzhen Comen Medical Instruments Co., Ltd. (10042479)
Roles: Contract manufacturer, Manufacturer
First device listed: November 30, 2012
Registered through: 2026
Brand names listed: C50, C50 and C80 Multi-parameter Patient Monitor, C60, C80, LED surgical Light, Multi-parameter Patient Monitor,Model C30, NC10 Multi-parameter Patient Monitor

Devices it lists

Device	Product code	Class	Role	Source
Alarm, Blood-Pressure	DSJ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Manufacturer	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Manufacturer	accessdata.fda.gov
Lamp, Surgical	FTD	2	Manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 29, 2022	K211619	Multi-Parameter Patient Monitor	MHX	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd	accessdata.fda.gov
December 13, 2019	K191106	C50 and C80 Multi-parameter Patient Monitor	MHX	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd	accessdata.fda.gov
August 16, 2018	K173454	Multi-parameter Patient Monitor, models C30	MHX	Substantially Equivalent	Shenzhen Comen Medical Instruments Co.,Ltd	accessdata.fda.gov
November 7, 2012	K112877	COMEN MULTI-PARAMETER PATIENT MONITOR	MWI	Substantially Equivalent	Goldway (Us), Inc.	accessdata.fda.gov

Compare with other makers

Updated December 29, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.