BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Extraoral X-Ray Unit

    Reg #: 8044167 · FEI: 3002772487 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ROLENCE ENT. INC.
    Registration Number
    8044167
    FEI Number
    3002772487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18-3 LANE 231 PU CHUNG RD.
    City
    CHUNGLI Taoyuan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K172928

    Owner / Operator

    Firm Name
    ROLENCE ENT. INC.
    Operator Number
    9005974
    Address
    18-3 LANE 231 PU CHUNG RD., --
    City
    CHUNGLI
    State
    Taoyuan
    Postal Code
    32083
    Country
    TW
    Correspondent
    STERLING - CHENG

    US Agent

    Business Name
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr.
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    Extraoral X-Ray Unit

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device