BEUDAMED
    FDA Registration Active 🇨🇳 China

    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

    Reg #: 3015136927 · FEI: 3015136927 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Registration Number
    3015136927
    FEI Number
    3015136927
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242514

    Owner / Operator

    Firm Name
    SHENZHEN ROGIN MEDICAL CO., LTD
    Operator Number
    10058732
    Address
    Rm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518129
    Country
    CN
    Correspondent
    Xiaoran Xu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

    Establishment Types

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