BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    WELL MEDICAL

    Reg #: 3025873468 · FEI: 3025873468 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    WELL MEDICAL
    Registration Number
    3025873468
    FEI Number
    3025873468
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rm 101, 646-3 Gobigogae-ro, Naega-myeon, Ganghwa-gun
    City
    Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K161500

    Owner / Operator

    Firm Name
    Well Medical
    Operator Number
    10087284
    Address
    Rm 101, 646-3 Gobigogae-ro, Naega-myeon, Ganghwa-gun
    City
    Incheon
    State
    KR-28
    Postal Code
    23018
    Country
    KR
    Correspondent
    JOONGKUG SHIN

    US Agent

    Business Name
    Salvin Dental Specialties
    Contact Name
    William Simmons
    Address
    3450 Latrobe Drive
    City
    Charlotte
    State
    NC
    ZIP
    28211
    Country
    US
    Email
    [email protected]
    Phone
    704 4425400

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    AUTOTORQ-35 OsseoScrape

    Establishment Types

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