BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    APOTECA Drug Compounding Dosing Device

    Reg #: 3006571738 · FEI: 3006571738 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AEA SRL
    Registration Number
    3006571738
    FEI Number
    3006571738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Fiume 16
    City
    Angeli di Rosora Ancona
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K132011

    Owner / Operator

    Firm Name
    AEA srl
    Operator Number
    10035140
    Address
    Via Fiume 16
    City
    Angeli di Rosora
    State
    Ancona
    Postal Code
    60030
    Country
    IT

    US Agent

    Business Name
    Loccioni Usa Inc.
    Contact Name
    IGNAZIO DROGHINI
    Address
    5600 Rivertech Court, Suite C-D
    City
    Riverdale
    State
    MD
    ZIP
    20737
    Country
    US
    Email
    [email protected]
    Phone
    803 7385151

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI
    Syringe, Piston FMF

    Proprietary Names

    APOTECA Drug Compounding Dosing Device APOTECA I.V. Transfer Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility