BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IRIS-XP

    Reg #: 2000010846 · FEI: 2000010846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDICORE CO. LTD.
    Registration Number
    2000010846
    FEI Number
    2000010846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 801 803, Joonganginnotech, 148, Sagimakgolro,, Jungwon-gu,
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K212412

    Owner / Operator

    Firm Name
    MEDICORE CO. LTD.
    Operator Number
    10025245
    Address
    No.801-803, Joonganginnotech, 148, Sagimakgolro, Jungwon-gu
    City
    Seongnam
    State
    Gyeonggi
    Postal Code
    13207
    Country
    KR
    Correspondent
    Byung-kuk YOO

    US Agent

    Business Name
    Long Life Cardio LLC
    Contact Name
    Wayne Baumgarten
    Address
    111 Joe Wimberley, Blvd #1304
    City
    Wimberley
    State
    TX
    ZIP
    78676
    Country
    US
    Email
    [email protected]
    Phone
    210 6102521

    Products

    Device Name Product Code
    System, Telethermographic (Adjunctive Use) LHQ

    Proprietary Names

    IRIS-XP

    Establishment Types

    Manufacture Medical Device