BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Temp Pal (Smart Thermometer Patch)

    Reg #: 3016870651 · FEI: 3016870651 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IWEECARE CO., LTD.
    Registration Number
    3016870651
    FEI Number
    3016870651
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    19F.-4, No. 2, Ln. 150, Sec. 5, Xinyi Rd., Xinyi Dist.,
    City
    Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K222588

    Owner / Operator

    Firm Name
    iWEECARE Co., Ltd.
    Operator Number
    10087642
    Address
    19F.-4., No. 2, Ln. 150, Sec. 5, Xinyi Rd., Xinyi Dist.
    City
    Taipei
    State
    TW-TPE
    Postal Code
    110
    Country
    TW
    Correspondent
    Jean Chen

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Temp Pal (Smart Thermometer Patch) Smart Temp Wireless Medical Thermometer

    Establishment Types

    Manufacture Medical Device