BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    BioButton™ remote patient monitoring device

    Reg #: 3008460104 · FEI: 3008460104 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    WISTRON MEDICAL TECHNOLOGY CORPORATION
    Registration Number
    3008460104
    FEI Number
    3008460104
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F, No.5, XIN-AN RD.,, Hsinchu Science Park,
    City
    Hsinchu City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K212957

    Owner / Operator

    Firm Name
    Wistron Medical Technology Corporation
    Operator Number
    10056677
    Address
    5F, NO.5, XIN-AN RD.,, Hsinchu Science Park,
    City
    Hsinchu City
    State
    TW-HSQ
    Postal Code
    300091
    Country
    TW
    Correspondent
    Peggy Tsai

    Products

    Device Name Product Code
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Calculator, Drug Dose NDC

    Proprietary Names

    BioButton™ remote patient monitoring device BioButton™ Rechargeable BioButton™ BioButton™ wearable device BioButton™ wearable sensor BioButton v3

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)