Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008716327

FEI Number

3008716327

Entity Name

SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment 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 518106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Comen Medical Instruments Co., Ltd. (Owner Number: 10042479)

Owner / Operator Contact Address

Floor10, 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, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191106

PMA Number

N/A

All Registered Proprietary Names

C50 C80 C60 Multi-parameter Patient Monitor,Model C30 LED surgical Light C50 and C80 Multi-parameter Patient Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-11-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-11-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2012-11-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-11-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-11-30
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-08-20
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2017-10-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-12-15
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2019-12-15
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2019-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-12-15
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-12-15
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-12-15
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2019-12-15
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-12-15
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-12-15
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2019-12-15
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2019-12-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-12-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-12-15
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-12-15
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-12-15
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2019-12-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-12-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-12-15
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2019-12-15
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2019-12-15
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-12-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2019-12-15

Official Correspondent

Gang Duan

US Agent Details

MARGARET VERNON Business: Biologics Consulting Email: contracts@biologicsconsulting.com Phone: (720) 8833633

Related Public Records

Same Entity

Shenzhen Comen Medical Instruments Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008716327. Last updated year: 2026. Please use registration number 3008716327 when referencing this establishment in official correspondence.