BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    AlcoCHECK FC300, AlcoCHECK FC90

    Reg #: 3007776657 · FEI: 3007766657 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SKYFINE INC. LIMITED
    Registration Number
    3007776657
    FEI Number
    3007766657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15/F., Dundas Square, 43H Dundas Street, Mongkok
    City
    KLN
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K091714

    Owner / Operator

    Firm Name
    SKYFINE Inc. Limited
    Operator Number
    10029263
    Address
    15/F., Dundas Square, 43H Dundas Street, Mongkok
    City
    KLN
    State
    HK-NOTA
    Postal Code
    999077
    Country
    HK
    Correspondent
    Jason Chiang

    US Agent

    Business Name
    SkyfineUSA inc.
    Contact Name
    Ali Najib
    Address
    11585 South State Street,
    City
    Draper
    State
    UT
    ZIP
    84020
    Country
    US
    Email
    [email protected]
    Phone
    801 8658910

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

    AlcoCHECK FC300, AlcoCHECK FC90 AlcoCHECK FC300e AT576, AT577, AT578, AT579 AlcoDigital Breathalyzer, Model

    Establishment Types

    Manufacture Medical Device