BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    MESI D.O.O.

    Reg #: 3011861727 · FEI: 3011861727 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MESI D.O.O.
    Registration Number
    3011861727
    FEI Number
    3011861727
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Stegne 11a
    City
    Ljubljana
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K201046

    Owner / Operator

    Firm Name
    MESI D.O.O.
    Operator Number
    10055183
    Address
    Stegne 11a
    City
    Ljubljana
    State
    SI-061
    Postal Code
    1000
    Country
    SI
    Correspondent
    Jakob Susteric

    US Agent

    Business Name
    Paladin Medical, Inc
    Contact Name
    Elaine Duncan
    Address
    415 Valley View Trl
    City
    Houlton
    State
    WI
    ZIP
    54082
    Country
    US
    Email
    [email protected]
    Phone
    715 5496035

    Products

    Device Name Product Code
    Plethysmograph, Photoelectric, Pneumatic Or Hydraulic JOM
    Electrocardiograph DPS
    Spirometer, Diagnostic BZG

    Proprietary Names

    MESI mTABLET ABI Automated Wireless Ankle-Brachial Index Measuring System MESI ABPI MD Automated Ankle-Brachial Pressure Index Measuring Device MESI mTABLET ECG Wireless 12-lead Resting ECG System MESI mTABLET TBI Wireless Toe Brachial Index System MESI mTABLET SPIRO Wireless spirometry system

    Establishment Types

    Manufacture Medical Device