BEUDAMED
    FDA Registration Active 🇵🇭 Philippines

    ARKRAY Industry West Inc.

    Reg #: 3013472743 · FEI: 3013472743 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    ARKRAY Industry West Inc.
    Registration Number
    3013472743
    FEI Number
    3013472743
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Main Avenue Cor. 3rd Street CEZ
    City
    Rosario Cavite
    Country
    PH

    Regulatory Submissions

    510(k) Number
    K091102

    Owner / Operator

    Firm Name
    ARKRAY Industry West,Inc.
    Operator Number
    10053944
    Address
    Main Avenue Cor. 3rd Street CEZ
    City
    Rosario
    State
    Cavite
    Postal Code
    4106
    Country
    PH

    US Agent

    Business Name
    ARKRAY Factory USA, Inc.
    Contact Name
    Yosuke Yamamoto
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US
    Email
    [email protected]
    Phone
    612 9461481

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Prescription Use Blood Glucose Meter For Near-Patient Testing PZI
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    ReliOn Premier Voice Blood Glucose Monitoring System GLUCOCARD Vital BGM System ASSURE PLATINUM BGM SYSTEM ReliOn Premier Classic Blood Glucose Monitoring System ReliOn Premier Compact Blood Glucose Monitoring System Multi-Lancet Device 2 Assure Titanium Blood Glucose Monitoring System Lancet

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device