BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    INSUPEN ORIGINAL Pen Needles

    Reg #: 3014165712 · FEI: 3014165712 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PIKDARE S.p.A.
    Registration Number
    3014165712
    FEI Number
    3014165712
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Saldarini Catelli 10
    City
    Casnate con Bernate Como
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K203792

    Owner / Operator

    Firm Name
    PIKDARE S.P.A.
    Operator Number
    10056365
    Address
    Via Saldarini Catelli 10
    City
    Casnate con Bernate
    State
    Como
    Postal Code
    22070
    Country
    IT
    Correspondent
    Roberta Zanoni

    US Agent

    Business Name
    HTL-Strefa, Inc.
    Contact Name
    Sylvie Verdon
    Address
    113 Towne Lake Pkwy
    City
    Woodstock
    State
    GA
    ZIP
    30188
    Country
    US
    Email
    [email protected]
    Phone
    770 5280410

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    INSUPEN ORIGINAL Pen Needles INSUPEN ADVANCED Pen Needles

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device