BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    CardioKey, Model CK100

    Reg #: 3013889955 · FEI: 3013889955 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEMECS, S.R.O.
    Registration Number
    3013889955
    FEI Number
    3013889955
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hlavna 1797/62
    City
    Vrable Nitriansky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K130294

    Owner / Operator

    Firm Name
    Semecs
    Operator Number
    10057935
    Address
    Hlavna 1797/62
    City
    Vrable
    State
    Nitriansky
    Postal Code
    95201
    Country
    SK
    Correspondent
    Martin Zabransky

    US Agent

    Business Name
    Braemar Manufacturing LLC
    Contact Name
    Roxanne Ramirez
    Address
    1285 Corporate Center Drive, Suite 150, Eagan, MN 55121, USA
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US
    Email
    [email protected]
    Phone
    612 5900795

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory (Without Analysis) MWJ

    Proprietary Names

    CardioKey, Model CK100

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)