BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Merz North America, Inc.

    Reg #: 2135225 · FEI: 3003407669 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    11

    Registration Details

    Registration Name
    Merz North America, Inc.
    Registration Number
    2135225
    FEI Number
    3003407669
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4133 Courtney St., Suite 10
    City
    FRANKSVILLE
    State
    WI
    ZIP
    53126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013243
    PMA Number
    P040047

    Owner / Operator

    Firm Name
    Merz North America, Inc.
    Operator Number
    9043404
    Address
    6501 Six Forks Road
    City
    Raleigh
    State
    NC
    Postal Code
    27615
    Country
    US
    Correspondent
    Bonnie Safyurtlu

    Products

    Device Name Product Code
    Instrument, Ent Manual Surgical LRC
    Needle, Aspiration And Injection, Disposable GAA
    Cannula, Surgical, General & Plastic Surgery GEA
    Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
    Agent, Bulking, Injectable For Gastro-Urology Use LNM
    Implant, Dermal, For Aesthetic Use LMH
    Implant, Dermal, For Aesthetic Use In The Hands PKY
    Single Use Instrument Tray OJV
    Needle, Gastro-Urology FHR
    System, Vocal Cord Medialization MIX
    Transparent Patch For Use In Treatment Of Tattoos PKO

    Proprietary Names

    Rigid Injection Needle CSH Cannula; STERiGLIDE Prolaryn Plus Injectable Implant Coaptite Injectable Implant Radiesse Injectable Implant Radiesse® (+) Accessory Kit Prolaryn Gel Injectable Implant Describe

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility