BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    PYLANT MONITOR

    Reg #: 3010806663 · FEI: 3010806663 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INORIS MEDICAL SP. Z O.O.
    Registration Number
    3010806663
    FEI Number
    3010806663
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ul. Zmkowa 9
    City
    Kowary Dolnoslaskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K191858

    Owner / Operator

    Firm Name
    Inoris Medical Sp. z o.o.
    Operator Number
    10046303
    Address
    ul. Zmkowa 9
    City
    Kowary
    State
    Dolnoslaskie
    Postal Code
    58-530
    Country
    PL
    Correspondent
    Pawel Gotowala

    US Agent

    Business Name
    KAL-MED, LLC
    Contact Name
    Robert Kaliski
    Address
    570 PERCIVAL AVE
    City
    Kensington
    State
    CT
    ZIP
    06037
    Country
    US
    Email
    [email protected]
    Phone
    585 6334225

    Products

    Device Name Product Code
    Cuff, Tracheal Tube, Inflatable BSK

    Proprietary Names

    PYLANT MONITOR

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device