BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TeleRPM Blood Glucose Monitoring System, Meter model: TMB-2282-G, Test strips model: TTS01

    Reg #: 3022418645 · FEI: 3022418645 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIO LABS INC.
    Registration Number
    3022418645
    FEI Number
    3022418645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    KCH, 575 Lexington Ave 14F New York
    City
    Franklin D Roosevelt
    State
    NY
    ZIP
    10022
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223722

    Owner / Operator

    Firm Name
    Mio Labs Inc.
    Operator Number
    10084983
    Address
    4500 Great America Pkwy Suite 1023
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Jialong Fan

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    TeleRPM Blood Glucose Monitoring System, Meter model: TMB-2282-G, Test strips model: TTS01 Pylo Blood Glucose Monitoring System, Meter model: GL1-LTE, Test strips model:GL1-STP-50 MIO Blood Glucose Monitoring System, model: TeleBGM2282-G

    Establishment Types

    Manufacture Medical Device