BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ReliOn Prime BGM System

    Reg #: 3003422726 · FEI: 3003422726 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARKRAY Factory, Inc.
    Registration Number
    3003422726
    FEI Number
    3003422726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1480 Koji, Konan-cho
    City
    Koka-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K091102

    Owner / Operator

    Firm Name
    ARKRAY, INC.
    Operator Number
    8030316
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    Postal Code
    33122
    Country
    US

    US Agent

    Business Name
    ARKRAY Factory USA, Inc.
    Contact Name
    Tom Speikers
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US
    Email
    [email protected]
    Phone
    952 6463168

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    ReliOn Prime BGM System GLUCOCARD Vital BGM System GLUCOCARD Vital Blood Glucose Test Strips

    Establishment Types

    Manufacture Medical Device