BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GENORAY AMERICA INC.

    Reg #: 3007538876 · FEI: 3007538876 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    GENORAY AMERICA INC.
    Registration Number
    3007538876
    FEI Number
    3007538876
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1220 N Simon Circle, Unit B
    City
    Anaheim
    State
    CA
    ZIP
    92806
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141700

    Owner / Operator

    Firm Name
    Genoray America Inc.
    Operator Number
    10029239
    Address
    1220 N Simon Circle, Unit B
    City
    Anaheim
    State
    CA
    Postal Code
    92806
    Country
    US
    Correspondent
    Nate Keum

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS

    Proprietary Names

    PAPAYA Plus PAPAYA 3D Plus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device