BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    GOLDEN SMART HOME TECHNOLOGY CORP.

    Reg #: 3015188281 · FEI: 3015188281 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    GOLDEN SMART HOME TECHNOLOGY CORP.
    Registration Number
    3015188281
    FEI Number
    3015188281
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 206, No.47, Yuanqu 2nd Rd., Hsinchu Science Park
    City
    Hsinchu City Hsinchu (City)
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K141351

    Owner / Operator

    Firm Name
    Golden Smart Home Technology Corp.
    Operator Number
    10060061
    Address
    Room 206, No.47, Yuanqu 2nd Rd., Hsinchu Science Park
    City
    Hsinchu City
    State
    TW-NOTA
    Postal Code
    30075
    Country
    TW

    US Agent

    Business Name
    BTS US Inc
    Contact Name
    Alex Gary
    Address
    1624 Market St
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    844 9823583

    Products

    Device Name Product Code
    Analyzer, Body Composition, Exempt PUH
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Continuous Measurement Thermometer FLL
    Oximeter, Infrared, Sporting, Aviation OCH
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    WowGoHealth Bluetooth Body Fat Analyzer GSH231 Series WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25 WowGoHealth Control Solution - GSH-BGM902 - Level 1 WowGoHealth Blood Glucose Monitoring System GSH-BGM902 WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301 WowGoHealth Pulse Oximeter GSH601 WowGoHealth Infrared Ear & Forehead Thermometer GSH-351 Automatic Arm Bluetooth Blood Pressure Monitor GSH862

    Establishment Types

    Manufacture Medical Device