BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    XK300

    Reg #: 3026751377 · FEI: 3026751377 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Xandar Kardian Korea Inc.
    Registration Number
    3026751377
    FEI Number
    3026751377
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 27, Gyeonghuigung-gil, Jongno-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K202464

    Owner / Operator

    Firm Name
    Xandar Kardian Inc.
    Operator Number
    10087145
    Address
    2F, 27, Gyeonghuigung-gil, Jongno-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    03176
    Country
    KR
    Correspondent
    Glen Choi

    US Agent

    Business Name
    Rook Quality Systems
    Contact Name
    Chandler Thames
    Address
    1155 Mount Vernon Hwy, #800
    City
    Dunwoody
    State
    GA
    ZIP
    30338
    Country
    US
    Email
    [email protected]
    Phone
    919 5880778

    Products

    Device Name Product Code
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Breathing Frequency BZQ

    Proprietary Names

    XK300

    Establishment Types

    Manufacture Medical Device