BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    SOLO V2

    Reg #: 3005862821 · FEI: 3005862821 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OK BIOTECH CO., LTD.
    Registration Number
    3005862821
    FEI Number
    3005862821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 91, SEC. 2, Gongdao 5th Rd.
    City
    HSINCHU CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K093764

    Owner / Operator

    Firm Name
    OK BIOTECH CO., LTD.
    Operator Number
    9090860
    Address
    No. 91, Sec. 2, Gongdao 5th Rd.
    City
    Hsinchu City
    State
    TW-HSQ
    Postal Code
    30070
    Country
    TW

    US Agent

    Business Name
    JS US Representative Office
    Contact Name
    Esther Liu
    Address
    162 Fuller St. Apt#1
    City
    Brookline
    State
    MA
    ZIP
    02446
    Country
    US
    Email
    [email protected]
    Phone
    404 9323207

    Products

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

    Proprietary Names

    SOLO V2

    Establishment Types

    Manufacture Medical Device