BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    microINR® Meter

    Reg #: 3015499222 · FEI: 3015499222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IKOR SISTEMAS ELECTRONICOS, SL
    Registration Number
    3015499222
    FEI Number
    3015499222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Empresarial Zuatzu s/n
    City
    San Sebastian Guipuzcoa
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K201185

    Owner / Operator

    Firm Name
    IKOR Sistemas Electronicos, SL
    Operator Number
    10060537
    Address
    Parque Empresarial Zuatzu s/n
    City
    San Sebastian
    State
    Guipuzcoa
    Postal Code
    20018
    Country
    ES
    Correspondent
    ESTIBALIZ CASTELRUIZ AGUIRRE

    US Agent

    Business Name
    Dawa Medical
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Test, Time, Prothrombin GJS

    Proprietary Names

    microINR® Meter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)