BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    R-Sensor

    Reg #: 3013779985 · FEI: 3013779985 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    REMEDI INC.
    Registration Number
    3013779985
    FEI Number
    3013779985
    Status
    Active
    Expiry Year
    2025
    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
    #1409, IS BIZ Tower, 26 Yangpyeong-ro 21-gil
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    072NN
    Country
    KR
    Correspondent
    Keedock Kim

    US Agent

    Business Name
    510KFDA, Inc.
    Contact Name
    Claude Berthoin
    Address
    156 E Granada Blvd
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8710908

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    R-Sensor

    Establishment Types

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