BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    COWELLMEDI CO., LTD.

    Reg #: 3005115116 · FEI: 3005115116 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    COWELLMEDI CO., LTD.
    Registration Number
    3005115116
    FEI Number
    3005115116
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    48, Hakgam-daero 221beon-gil, Sasang-Gu
    City
    BUSAN
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K050635

    Owner / Operator

    Firm Name
    COWELLMEDI CO., LTD.
    Operator Number
    9071264
    Address
    48, Hakgam-Daero 221beon-Gil, Sasang-Gu
    City
    Busan
    State
    KR-26
    Postal Code
    46986
    Country
    KR
    Correspondent
    MINJIN PARK

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave STE 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Abutment, Implant, Dental, Endosseous NHA
    Screwdriver, Surgical LRZ
    Drill, Dental, Intraoral DZA
    Accessories, Retractor, Dental EIF
    Barrier, Synthetic, Intraoral NPK

    Proprietary Names

    AIIFIM Implant System Dental Implant System_Instrument INNO SLA Mini Plus® Implant System KAPD13L Cowell Implant System Meta G UCLA Abutment ATLAS Implant System - Wide Plus INNO SLA Submerged Implant System SFIT Abutment ATLAS Implant System BIO PLANT SYSTEM INNO SLA Sub Narrow Implant System ATLAS Implant Wywtem - Mini Plus InnoGenic Non-resorbable Membrane INNO SLA Sub Ti-base System

    Establishment Types

    Manufacture Medical Device