BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMK IMAGING LLC

    Reg #: 3010609444 · FEI: 3010609444 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    SMK IMAGING LLC
    Registration Number
    3010609444
    FEI Number
    3010609444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    8 Westchester Plz Ste 112
    City
    Elmsford
    State
    NY
    ZIP
    10523
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123419

    Owner / Operator

    Firm Name
    SMK Imaging LLC
    Operator Number
    10045679
    Address
    8 Westchester Plaza, Suite 112
    City
    Elmsford
    State
    NY
    Postal Code
    10523
    Country
    US
    Correspondent
    James Johnson

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    EVA Select Digital Dental Imaging System EVA Select Size #1 EVA Select Size #2 EVA Select EVA SELECT DIRECT SIZE #1 EVA SELECT DIRECT SIZE #2 EVA SELECT DIRECT

    Establishment Types

    Manufacture Medical Device