BEUDAMED
    FDA Registration Active 🇨🇳 China

    C60

    Reg #: 3008716327 · FEI: 3008716327 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
    Registration Number
    3008716327
    FEI Number
    3008716327
    Status
    Active
    Expiry Year
    2025
    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 400
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    720 8833633

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Electrocardiograph DPS
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    C60 C80 C50

    Establishment Types

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