BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    REMEDI INC.

    Reg #: 3013779985 · FEI: 3013779985 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    REMEDI INC.
    Registration Number
    3013779985
    FEI Number
    3013779985
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, 69-14, Sakju-ro 145beon-gil
    City
    Chuncheon Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200284

    Owner / Operator

    Firm Name
    Remedi Inc.
    Operator Number
    10060424
    Address
    2F, 69-14, Sakju-Ro 145beon-Gil
    City
    Chuncheon
    State
    Gangwon
    Postal Code
    072NN
    Country
    KR

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    R-Sensor T-100 REMEX-T100 MobileX T-100 REMEX KA6 ES70 REMEX Xcam6 REMEX-GR100

    Establishment Types

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