BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    PENCYLCAP

    Reg #: 3003581732 · FEI: 3003581732 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MERCK SERONO S.P.A.
    Registration Number
    3003581732
    FEI Number
    3003581732
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via delle Magnolie, 15 (Loc. Frazione Zona Industriale)
    City
    Modugno Bari
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K152050

    Owner / Operator

    Firm Name
    Merck Serono S.p.A.
    Operator Number
    10061648
    Address
    Via delle Magnolie, 15 (Loc. Frazione Zona Industriale)
    City
    Modugno
    State
    Bari
    Postal Code
    70026
    Country
    IT
    Correspondent
    Vahid Mostaghimi

    US Agent

    Business Name
    EMD SERONO INC.
    Contact Name
    Jamie Yieh
    Address
    200 Pier 4 Blvd
    City
    Boston
    State
    MA
    ZIP
    02210
    Country
    US
    Email
    [email protected]
    Phone
    781 4905838

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    PENCYLCAP

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device