BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    U-NEEDLE B.V.

    Reg #: 3009853488 · FEI: 3009853488 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    U-NEEDLE B.V.
    Registration Number
    3009853488
    FEI Number
    3009853488
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    De Veldmaat 10
    City
    Enschede Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K190962

    Owner / Operator

    Firm Name
    U-Needle BV
    Operator Number
    10080399
    Address
    De Veldmaat, 10
    City
    Enschede
    State
    Overijssel
    Postal Code
    7522NM
    Country
    NL
    Correspondent
    Jeroen Wissink

    US Agent

    Business Name
    Medical Device Academy Incorporated
    Contact Name
    Robert Packard
    Address
    345 Lincoln Hill Rd
    City
    Cuttingsville
    State
    VT
    ZIP
    05738
    Country
    US
    Email
    [email protected]
    Phone
    802 2581881

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Bella-mu

    Establishment Types

    Manufacture Medical Device