BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    N.V. Organon

    Reg #: 3002806821 · FEI: 3002806821 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    N.V. Organon
    Registration Number
    3002806821
    FEI Number
    3002806821
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kloosterstraat 6
    City
    Oss Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K162516

    Owner / Operator

    Firm Name
    Organon LLC
    Operator Number
    10082609
    Address
    30 Hudson Street
    City
    Jersey City
    State
    NJ
    Postal Code
    07302
    Country
    US
    Correspondent
    Suraj Ramachandran

    US Agent

    Business Name
    Organon LLC
    Contact Name
    Suraj Ramachandran
    Address
    30 Hudson St
    City
    Jersey City
    State
    NJ
    ZIP
    07302
    Country
    US
    Email
    [email protected]
    Phone
    551 4306231

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    FOLLISTIM PEN & Pen Needles

    Establishment Types

    Repack or Relabel Medical Device