BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    SyntheCel Dura Repair

    Reg #: 3012479318 · FEI: 3012479318 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOWIL BIOTECH SP. Z O.O. (LTD.)
    Registration Number
    3012479318
    FEI Number
    3012479318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7, Skandynawska Street
    City
    Wladyslawowo Pomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K212943

    Owner / Operator

    Firm Name
    BOWIL Biotech Sp. z o.o. (Ltd.)
    Operator Number
    10060839
    Address
    7, Skandynawska Street
    City
    Wladyslawowo
    State
    Pomorskie
    Postal Code
    84 120
    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
    Dura Substitute GXQ

    Proprietary Names

    SyntheCel Dura Repair

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)