BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    ENBIO TECHNOLOGY SP. Z.O.O.

    Reg #: 3018815412 · FEI: 3018815412 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ENBIO TECHNOLOGY SP. Z.O.O.
    Registration Number
    3018815412
    FEI Number
    3018815412
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Polnocna 10 Street
    City
    Gdynia Pomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K260254

    Owner / Operator

    Firm Name
    Enbio Technology Sp. z.o.o.
    Operator Number
    10084687
    Address
    Dzialkowcow 15 Street
    City
    Rumia
    State
    PL-NOTA
    Postal Code
    PL-84-230
    Country
    PL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Sterilizer, Steam FLE

    Proprietary Names

    Enbio PRO Enbio S

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device