BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.

    Reg #: 3008716327 · FEI: 3008716327 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    24

    Registration Details

    Registration Name
    SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
    Registration Number
    3008716327
    FEI Number
    3008716327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    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
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112877

    Owner / Operator

    Firm Name
    Shenzhen Comen Medical Instruments Co., Ltd.
    Operator Number
    10042479
    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
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN
    Correspondent
    Gang Duan

    US Agent

    Business Name
    Biologics Consulting
    Contact Name
    MARGARET VERNON
    Address
    100 DAINGERFIELD ROAD, SUITE 101
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    720 8833633

    Products

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

    Proprietary Names

    C50 C80 C60 Multi-parameter Patient Monitor,Model C30 LED surgical Light C50 and C80 Multi-parameter Patient Monitor NC10 Multi-parameter Patient Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device