BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infrared forehead thermometer

    Reg #: 3007703436 · FEI: 3007703436 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WENZHOU CARETEK MEDICAL DEVICE CO., LTD
    Registration Number
    3007703436
    FEI Number
    3007703436
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 1301.Yue Shang Mansion.Nanhui.Lucheng.
    City
    Wenzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160999

    Owner / Operator

    Firm Name
    Wenzhou Caretek Medical Device Co., Ltd
    Operator Number
    10029464
    Address
    Room 1301.Yue Shang Mansion.Nanhui.Lucheng.
    City
    Wenzhou
    State
    Zhejiang
    Postal Code
    325000
    Country
    CN
    Correspondent
    Yuan L Huang

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD
    Contact Name
    Marcos Wu
    Address
    2219 Rimland Drive, Suite 301, Bellingham, Barkley Villiage
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Infrared forehead thermometer

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device