BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Decapinol Oral Rinse

    Reg #: 3003311293 · FEI: 3003311293 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sigmar Italia S.P.A
    Registration Number
    3003311293
    FEI Number
    3003311293
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA SOMBRENO, 11
    City
    ALME Bergamo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    DEN050001

    Owner / Operator

    Firm Name
    SIGMAR ITALIA S.P.A
    Operator Number
    9080151
    Address
    VIA SOMBRENO, 11
    City
    ALME, BERGAMO
    State
    IT-NOTA
    Postal Code
    24011
    Country
    IT

    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
    Rinse, Oral, Antibacterial (By Physical Means) NTO

    Proprietary Names

    Decapinol Oral Rinse

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)