BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    NANOTITE TM CERTAIN® PREVAIL® IMPLANT

    Reg #: 3010392243 · FEI: 3010392243 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aragogamma, S.L.
    Registration Number
    3010392243
    FEI Number
    3010392243
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CTRA. Granollers A Cardedeu (C-251) Km 3.5
    City
    Les Franqueses del Valles Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K051461

    Owner / Operator

    Firm Name
    Aragogamma, S.L.
    Operator Number
    10043825
    Address
    Salvador Mundi, 11 Bajos
    City
    Barcelona
    State
    ES-NOTA
    Postal Code
    E-08017
    Country
    ES
    Correspondent
    Anna Arago

    US Agent

    Business Name
    Pharma-Bio Serv
    Contact Name
    Victor Sanchez
    Address
    6 CARR 696
    City
    DORADO
    State
    PR
    ZIP
    00646
    Country
    US
    Email
    [email protected]
    Phone
    787 2782709

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    NANOTITE TM CERTAIN® PREVAIL® IMPLANT

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)