BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Fever Scout™ Continuous Monitoring Thermometer

    Reg #: 3038610665 · FEI: 3038610665 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HOCHUEN MEDICAL SDN. BHD.
    Registration Number
    3038610665
    FEI Number
    3038610665
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC
    City
    SENAI Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K162137

    Owner / Operator

    Firm Name
    Hochuen Medical Sdn. Bhd.
    Operator Number
    10093449
    Address
    62 Jalan I-Park SAC 6, Taman Perindustrian I-Park SAC
    City
    SENAI
    State
    Johor
    Postal Code
    81400
    Country
    MY

    US Agent

    Business Name
    MEDRIGHT TECH INC
    Contact Name
    Jessie Yao
    Address
    6302 FORT HAMILTON PARKWAY, 1R
    City
    Brooklyn
    State
    NY
    ZIP
    11219
    Country
    US
    Email
    [email protected]
    Phone
    718 2169957

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Fever Scout™ Continuous Monitoring Thermometer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)